Draft Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Device Studies-Frequently Asked Questions; Availability, 60682-60683 [E7-20982]

Download as PDF 60682 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices Rockville, MD 20857; or the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852–1448. The draft guidance may also be obtained from the Center for Biologics Evaluation and Research by mail by calling 1–800–835– 4709 or 301–827–1800. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: mstockstill on PROD1PC66 with NOTICES Tom Moreno, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5143, Silver Spring, MD 20993–0002, 301–796–0878; or Bruce Schneider, Center for Biologics Evaluation and Research (HFM– 755), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301– 827–5102. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Drug-Induced Liver Injury: Premarketing Clinical Evaluation.’’ Idiosyncratic hepatotoxicity is an important cause of drug withdrawal and has led to considerable FDA attention to the subject, beginning with a conference on hepatotoxicity at the National Institutes of Health in 1978. The science of detecting and evaluating DILI during drug development is evolving, and FDA is working with industry, academia, and other government groups toward better understanding of the problems and what to do about them. Even drugs that prove to be significant hepatotoxins (e.g, bromfenac and troglitazone) are unlikely to show cases of severe DILI during a drug development program with at most several thousand exposed subjects. Therefore, it is critical during drug development to discover less severe DILI that may indicate a potential for the drug to cause severe DILI. There are a number of signals of liver injury that have varying levels of sensitivity and specificity in predicting potential for VerDate Aug<31>2005 17:26 Oct 24, 2007 Jkt 214001 severe DILI. An increased rate of elevated aminotransferase (AT) levels compared to control is a highly sensitive indicator of potential severe hepatotoxicity, but many drugs that do not cause severe injury show AT elevations, so the specificity of this test as a predictor of a potential for severe hepatotoxicity is poor. Specificity is increased when the signal used is the occurrence of more marked AT elevation (to 5-, 10-, 20xULN), but the most specific finding to date is an overall pattern of AT elevation together with elevated bilirubin (and no evidence of bile obstruction) in a small number of subjects. This guidance describes the sensitivity and specificity of various indicators of hepatotoxic potential, as well as the observations needed to evaluate those indicators, including detection, confirmation, and monitoring of liver test abnormalities, close evaluation and exclusion of other causes, and careful supportive care and followup to normality or return to baseline status. 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 premarketing clinical evaluation of drug-induced liver injury. 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 statutes and regulations. II. The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that 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 parts 312, 314, and 600 have been approved under OMB control numbers 0910–0014, 0910–0001, and 0910–0338, respectively. III. 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 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the document at https:// www.fda.gov/cder/guidance/index.htm, https://www.fda.gov/cber/ guidelines.htm, or https://www.fda.gov/ ohrms/dockets/default.htm. Dated: October 19, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–21060 Filed 10–24–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0387] Draft Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Device Studies—Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies—Frequently Asked Questions.’’ This draft guidance document contains information to assist manufacturers in developing and conducting studies for IVD devices, particularly those exempt from most of the Investigational Device Exemption (IDE) regulations. This draft guidance is neither final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115)(g)(5)), to ensure that the agency considers your comment on this draft before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 23, 2008. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Draft Guidance for Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies— Frequently Asked Questions’’ 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 selfaddressed adhesive label to assist that E:\FR\FM\25OCN1.SGM 25OCN1 Federal Register / Vol. 72, No. 206 / Thursday, October 25, 2007 / Notices 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 either 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: Sally Hojvat, Center for Devices and Radiological Health (HFZ–312), Food and Drug Administration,2098 Gaither Rd, Rockville, MD 20850, 301–594–5940, ext. 114; or Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background This draft guidance is intended to facilitate the movement of new IVD technology from the investigational stage to the marketing stage by providing information about the development and conduct of IVD studies that will be submitted to the agency to support premarket notifications and applications. Because many IVD studies are exempt from most of the IDE regulations at part 812 (21 CFR part 812) (§ 812.2(c)(3)), both industry sponsors and FDA staff often have questions concerning the relevant requirements and appropriate methods for such studies. This draft guidance provides information about such studies as well as general information about the development, conduct, and responsibilities associated with all IVD studies. The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) both have regulatory oversight of IVD devices. Information in this draft guidance is relevant to IVD devices regulated by either center under subchapter H of 21 CFR Chapter I. mstockstill on PROD1PC66 with NOTICES II. 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 IVD device studies. It does not create or confer any rights for or on any person VerDate Aug<31>2005 17:26 Oct 24, 2007 Jkt 214001 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 draft guidance may do so by using the Internet. To receive ‘‘Draft Guidance for Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies— Frequently Asked Questions’’ 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 1587 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 CBER Internet site at https:// www.fda.gov/cber/guidelines.htm or on the Division of Dockets Management Internet site at https://www.fda.gov/ ohrms/dockets. IV. Paperwork Reduction Act of 1995 This draft 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 PRA). The collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910–0130; the collections of information in 21 CFR part 803 have been approved under OMB control number 0910–0437; the collections of information in 21 CFR 807.87 have been approved under OMB control number 0910–0120; the collections of information in 21 CFR 809.10 have been approved under OMB control number 0910–0485; the collections of information in 21 CFR PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 60683 part 810 have been approved under OMB control number 0910–0432; the collections of information under part 812 have been approved under OMB control number 0910–0078; the collections of information in part 814 (21 CFR part 814), subparts B and E, have been approved under OMB control number 0910–0231; the collections of information in part 814, subpart H, have been approved under OMB control number 0910–0332; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910–0073. V. 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 18, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–20982 Filed 10–24–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D–0168] Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ‘‘Bioequivalence Recommendations for Specific Products,’’ explaining the process that would be used to make product-specific BE recommendations available to the public on FDA’s Web E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Notices]
[Pages 60682-60683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20982]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0387]


Draft Guidance for Industry and Food and Drug Administration 
Staff; In Vitro Diagnostic Device Studies--Frequently Asked Questions; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Draft Guidance for 
Industry and FDA Staff; In Vitro Diagnostic (IVD) Device Studies--
Frequently Asked Questions.'' This draft guidance document contains 
information to assist manufacturers in developing and conducting 
studies for IVD devices, particularly those exempt from most of the 
Investigational Device Exemption (IDE) regulations. This draft guidance 
is neither final nor is it in effect at this time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115)(g)(5)), to ensure that the agency considers your comment on 
this draft before it begins work on the final version of the guidance, 
submit written or electronic comments on the draft guidance by January 
23, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and FDA Staff; 
In Vitro Diagnostic (IVD) Device Studies--Frequently Asked Questions'' 
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

[[Page 60683]]

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 either 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:
    Sally Hojvat, Center for Devices and Radiological Health (HFZ-312), 
Food and Drug Administration,2098 Gaither Rd, Rockville, MD 20850, 301-
594-5940, ext. 114; or
    Stephen M. Ripley, Center for Biologics Evaluation and Research 
(HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to facilitate the movement of new 
IVD technology from the investigational stage to the marketing stage by 
providing information about the development and conduct of IVD studies 
that will be submitted to the agency to support premarket notifications 
and applications. Because many IVD studies are exempt from most of the 
IDE regulations at part 812 (21 CFR part 812) (Sec.  812.2(c)(3)), both 
industry sponsors and FDA staff often have questions concerning the 
relevant requirements and appropriate methods for such studies. This 
draft guidance provides information about such studies as well as 
general information about the development, conduct, and 
responsibilities associated with all IVD studies. The Center for 
Devices and Radiological Health (CDRH) and the Center for Biologics 
Evaluation and Research (CBER) both have regulatory oversight of IVD 
devices. Information in this draft guidance is relevant to IVD devices 
regulated by either center under subchapter H of 21 CFR Chapter I.

II. 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 IVD device 
studies. 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 draft guidance may do 
so by using the Internet. To receive ``Draft Guidance for Industry and 
FDA Staff; In Vitro Diagnostic (IVD) Device Studies--Frequently Asked 
Questions'' 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 
1587 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 CBER Internet site at https://www.fda.gov/cber/
guidelines.htm or on the Division of Dockets Management Internet site 
at https://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This draft 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 
PRA). The collections of information in 21 CFR parts 50 and 56 have 
been approved under OMB control number 0910-0130; the collections of 
information in 21 CFR part 803 have been approved under OMB control 
number 0910-0437; the collections of information in 21 CFR 807.87 have 
been approved under OMB control number 0910-0120; the collections of 
information in 21 CFR 809.10 have been approved under OMB control 
number 0910-0485; the collections of information in 21 CFR part 810 
have been approved under OMB control number 0910-0432; the collections 
of information under part 812 have been approved under OMB control 
number 0910-0078; the collections of information in part 814 (21 CFR 
part 814), subparts B and E, have been approved under OMB control 
number 0910-0231; the collections of information in part 814, subpart 
H, have been approved under OMB control number 0910-0332; and the 
collections of information in 21 CFR part 820 have been approved under 
OMB control number 0910-0073.

V. 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 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20982 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S

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