``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV;'' Availability, 48658-48659 [E7-16605]

Download as PDF 48658 Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices Dated: August 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–16795 Filed 8–23–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2007M–0244 and 2007M–0263] Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA’s Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please include the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness data. FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register, providing instead to post this information on the Internet at https:// www.fda.gov. In addition, the regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during the quarter. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register. In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting administrative reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The following is a list of PMAs approved by CBER for which summaries of safety and effectiveness data were placed on the Internet from April 1, 2007, through June 30, 2007. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the approval date. TABLE 1.—LIST OF SUMMARIES OF SAFETY AND EFFECTIVENESS DATA FOR APPROVED PMAS MADE AVAILABLE APRIL 1, 2007, THROUGH JUNE 30, 2007 PMA No./Docket No. Applicant Trade name BP060002/0/2007M–0244 Abbott Molecular, Inc. Abbott RealTime HIV–1 Amplification Reagent Kit, Abbott RealTime HIV–1 Calibrator Kit, and Abbott RealTime HIV–1 Control Kit May 11, 2007 BP050069/0/2007M–0263 Roche Molecular Systems, Inc. COBAS AmpliPrep/COBAS TaqmanHIV–1 Test, 48 Tests, COBAS Ampliprep/COBAS Taqman Wash Reagent, 5.1.L May 11, 2007 II. Electronic Access DEPARTMENT OF HEALTH AND HUMAN SERVICES Persons with access to the Internet may obtain the documents at https:// www.fda.gov/cber/products.htm. Food and Drug Administration Dated: August 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–16706 Filed 8–23–07; 8:45 am] yshivers on PROD1PC66 with NOTICES BILLING CODE 4160–01–S [Docket No. 1999D–1878 (formerly Docket No. 99D–1878)] ‘‘Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV;’’ Availability AGENCY: Food and Drug Administration, HHS. VerDate Aug<31>2005 14:35 Aug 23, 2007 Jkt 211001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Approval date ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV,’’ dated August 2007. The guidance document provides recommendations for complying with the HCV ‘‘Lookback’’ requirements. This guidance document finalizes the guidance entitled, ‘‘Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and E:\FR\FM\24AUN1.SGM 24AUN1 yshivers on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (AntiHCV)’’ dated June 1999. Additionally, this guidance document supersedes the HCV sections of the FDA memorandum entitled, ‘‘Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T– Lymphotropic Virus Type I (HTLV–I),’’ dated July 19, 1996; and also supersedes the document entitled, ‘‘Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (AntiHCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV’’ dated September 1998. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule entitled ‘‘Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (‘Lookback’).’’ DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. 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. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for Biologics VerDate Aug<31>2005 14:35 Aug 23, 2007 Jkt 211001 Evaluation and Research (HFM–17), Food and Drug Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: ‘Lookback’ for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV,’’ dated August 2007. The guidance document provides recommendations to blood collecting establishments, hospitals, and other consignees for appropriate action when a repeat donor subsequently tests repeatedly reactive for HCV using either a single antigen or multiantigen screening test, or reactive using a direct viral detection test, e.g., HCV ribonucleic acid (RNA) nucleic acid tests (NAT). This procedure is commonly referred to as HCV ‘‘lookback.’’ The guidance document provides guidance for the following: • Quarantining of prior collections that remain in inventory; • Notifying consignees to quarantine prior collections; • Further testing of the donor; • Destroying or labeling potentially infectious prior collections; and • Notifying transfusion recipients who received blood from a donor who is later determined to be infected with HCV, if appropriate. This guidance document finalizes the guidance entitled, ‘‘Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (AntiHCV)’’ dated June 1999. Additionally, this guidance document supersedes the HCV sections of the FDA memorandum entitled, ‘‘Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T– Lymphotropic Virus Type I (HTLV–I),’’ dated July 19, 1996; and also supersedes the guidance entitled, ‘‘Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 48659 Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (AntiHCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV’’ dated September 1998. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this 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 alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. 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 1955 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 606.121, and 610.40 have been approved under OMB control number 0910–0116; the collections of information in 21 CFR 610.47 and 610.48 have been approved under OMB control number 0910–0460; and the collections of information in 21 CFR 640.70 have been approved under OMB control number 0910–0338. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance. 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 the 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. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. Dated: July 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–16605 Filed 8–23–07; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\24AUN1.SGM 24AUN1

Agencies

[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Notices]
[Pages 48658-48659]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16605]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-1878 (formerly Docket No. 99D-1878)]


``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): 
Product Quarantine, Consignee Notification, Further Testing, Product 
Disposition, and Notification of Transfusion Recipients Based on Donor 
Test Results Indicating Infection with HCV;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: `Lookback' 
for Hepatitis C Virus (HCV): Product Quarantine, Consignee 
Notification, Further Testing, Product Disposition, and Notification of 
Transfusion Recipients Based on Donor Test Results Indicating Infection 
with HCV,'' dated August 2007. The guidance document provides 
recommendations for complying with the HCV ``Lookback'' requirements. 
This guidance document finalizes the guidance entitled, ``Draft 
Guidance for Industry: Current Good Manufacturing Practice for Blood 
and

[[Page 48659]]

Blood Components: (1) Quarantine and Disposition of Prior Collections 
from Donors with Repeatedly Reactive Screening Tests for Hepatitis C 
Virus (HCV); (2) Supplemental Testing, and the Notification of 
Consignees and Transfusion Recipients of Donor Test Results for 
Antibody to HCV (Anti-HCV)'' dated June 1999. Additionally, this 
guidance document supersedes the HCV sections of the FDA memorandum 
entitled, ``Recommendations for the Quarantine and Disposition of Units 
from Prior Collections from Donors with Repeatedly Reactive Screening 
Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human 
T-Lymphotropic Virus Type I (HTLV-I),'' dated July 19, 1996; and also 
supersedes the document entitled, ``Guidance for Industry: Current Good 
Manufacturing Practice for Blood and Blood Components: (1) Quarantine 
and Disposition of Units from Prior Collections from Donors with 
Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus 
(Anti-HCV); (2) Supplemental Testing, and the Notification of 
Consignees and Blood Recipients of Donor Test Results for Anti-HCV'' 
dated September 1998.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule entitled ``Current Good Manufacturing Practice for Blood 
and Blood Components; Notification of Consignees and Transfusion 
Recipients Receiving Blood and Blood Components at Increased Risk of 
Transmitting Hepatitis C Virus Infection (`Lookback').''

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and 
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 
20852-1448. Send one self-addressed adhesive label to assist the office 
in processing your requests. The guidance may also be obtained by mail 
by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    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. Submit electronic comments to https://
www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): 
Product Quarantine, Consignee Notification, Further Testing, Product 
Disposition, and Notification of Transfusion Recipients Based on Donor 
Test Results Indicating Infection with HCV,'' dated August 2007. The 
guidance document provides recommendations to blood collecting 
establishments, hospitals, and other consignees for appropriate action 
when a repeat donor subsequently tests repeatedly reactive for HCV 
using either a single antigen or multiantigen screening test, or 
reactive using a direct viral detection test, e.g., HCV ribonucleic 
acid (RNA) nucleic acid tests (NAT). This procedure is commonly 
referred to as HCV ``lookback.'' The guidance document provides 
guidance for the following:
     Quarantining of prior collections that remain in 
inventory;
     Notifying consignees to quarantine prior collections;
     Further testing of the donor;
     Destroying or labeling potentially infectious prior 
collections; and
     Notifying transfusion recipients who received blood from a 
donor who is later determined to be infected with HCV, if appropriate.
    This guidance document finalizes the guidance entitled, ``Draft 
Guidance for Industry: Current Good Manufacturing Practice for Blood 
and Blood Components: (1) Quarantine and Disposition of Prior 
Collections from Donors with Repeatedly Reactive Screening Tests for 
Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification 
of Consignees and Transfusion Recipients of Donor Test Results for 
Antibody to HCV (Anti-HCV)'' dated June 1999. Additionally, this 
guidance document supersedes the HCV sections of the FDA memorandum 
entitled, ``Recommendations for the Quarantine and Disposition of Units 
from Prior Collections from Donors with Repeatedly Reactive Screening 
Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human 
T-Lymphotropic Virus Type I (HTLV-I),'' dated July 19, 1996; and also 
supersedes the guidance entitled, ``Guidance for Industry: Current Good 
Manufacturing Practice for Blood and Blood Components: (1) Quarantine 
and Disposition of Units from Prior Collections from Donors with 
Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus 
(Anti-HCV); (2) Supplemental Testing, and the Notification of 
Consignees and Blood Recipients of Donor Test Results for Anti-HCV'' 
dated September 1998.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this 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 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. 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 1955 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 606.121, and 610.40 have been 
approved under OMB control number 0910-0116; the collections of 
information in 21 CFR 610.47 and 610.48 have been approved under OMB 
control number 0910-0460; and the collections of information in 21 CFR 
640.70 have been approved under OMB control number 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding this guidance. 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 the 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/
ohrms/dockets/default.htm.

    Dated: July 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16605 Filed 8-23-07; 8:45 am]
BILLING CODE 4160-01-S

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