Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes; Availability, 44560-44561 [E7-15472]

Download as PDF 44560 Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Notices December 15, 2006 (Docket No. 2006P– 0520/CP1), under 21 CFR 10.30, requesting that the agency determine whether methotrexate injection, preservative free, Eq. 500 mg base/20 mL (25 mg/mL), was withdrawn from sale for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that methotrexate injection, preservative free, Eq. 500 mg base/20 mL (25 mg/mL), was withdrawn from sale for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate this product was withdrawn for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA has determined that, for the reasons outlined in this document, methotrexate injection, preservative free, Eq. 500 mg base/20 mL (25 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list methotrexate injection, preservative free, Eq. 500 mg base/20 mL (25 mg/ mL), in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to methotrexate injection, preservative free, Eq. 500 mg base/20 mL (25 mg/ mL), may be approved by the agency as long as they meet all relevant legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: July 30, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–15490 Filed 8–7–07; 8:45 am] sroberts on PROD1PC70 with NOTICES BILLING CODE 4160–01–S VerDate Aug<31>2005 19:14 Aug 07, 2007 Jkt 211001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002D–0081] Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes; 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: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes’’ dated July 2007. The guidance document provides recommendations to manufacturers of HBsAg assays that are intended to test donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and to establishments using an HBsAg assay. Topics include recommendations on minimum sensitivity standards for HBsAg assays. This guidance finalizes the draft guidance entitled ‘‘Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations’’ dated April 2002. DATES: Submit written or electronic comments on agency guidances at any time. 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 ADDRESSES: PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 electronic comments to https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., 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 FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes’’ dated July 2007. The guidance document provides recommendations to manufacturers of HBsAg assays that are approved donor screening tests intended to screen donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes for Hepatitis B, and to establishments using an HBsAg assay (See § 610.40(b) (21 CFR 610.40(b)). The document represents FDA’s current thinking on minimum sensitivity for such HBsAg assays as they relate to donor testing ‘‘to reduce adequately and appropriately the risk of transmission of communicable disease’’ under § 610.40(b). Under 21 CFR 610.44, the manufacturers of HBsAg assays used to test donations must verify acceptable sensitivity and specificity of such kits by testing the kit-lots using an FDA reference panel. This guidance document recommends that all HBsAg detection assays used to test donors of Whole Blood and blood components, including Source Plasma and Source Leukocytes, have a lower limit of detection standard of 0.5ng HBsAg/mL or less. In the Federal Register of April 11, 2002 (67 FR 17704), FDA announced the availability of the draft guidance entitled ‘‘Guidance for Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations.’’ FDA received a few comments on the draft guidance, and those comments were considered as the guidance was finalized. In addition, editorial changes were made to improve clarity. The recommended implementation date for the recommendations in this guidance is January 31, 2008. This guidance document finalizes the draft guidance document entitled ‘‘Guidance for E:\FR\FM\08AUN1.SGM 08AUN1 Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Notices Industry: A Modified Lot-Release Specification for Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma Donations’’ dated April 2002. The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the 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. Comments Interested persons may, at any time, submit to the Division of Dockets Management written or electronic comments (see ADDRESSES) regarding the 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. HIV Drug Resistance Genotype Assay,’’ dated August 2007. The guidance document provides a means by which in vitro human immunodeficiency virus (HIV) drug resistance genotype assays may comply with special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule classifying the in vitro HIV drug resistance genotype assay into class II (special controls). The guidance announced in this notice finalizes the draft guidance entitled ‘‘Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls’’ dated August 2001. DATES: Submit written or electronic comments on agency guidances at any time. Food and Drug Administration 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, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: [Docket No. 2001D–0286] I. Background III. 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: August 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–15472 Filed 8–7–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Guidance for Industry: Class II Special Controls Guidance Document: In Vitro Human Immunodeficiency Virus Drug Resistance Genotype Assay; Availability AGENCY: Food and Drug Administration, sroberts on PROD1PC70 with NOTICES HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Class II Special Controls Guidance Document: In Vitro SUMMARY: VerDate Aug<31>2005 19:14 Aug 07, 2007 Jkt 211001 ADDRESSES: FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay,’’ dated August 2007. This guidance document was developed as a special control to support classification of the in vitro HIV drug resistance genotype assay from class III to class II (special controls). Also, it is intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs as an aid in monitoring and treating HIV infection. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 44561 In the Federal Register of August 29, 2001 (66 FR 45682), FDA announced the availability of the draft guidance entitled ‘‘Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls’’ dated August 2001. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance entitled ‘‘Guidance for Industry: Premarket Notifications [510(k)s] for In Vitro HIV Drug Resistance Genotype Assays: Special Controls’’ dated August 2001. II. Significance of the Guidance The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’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. 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 21 CFR part 807, subpart E (regulations governing premarket notification submissions) have been approved under OMB control number 0910–0120. IV. Comments Interested persons may, at any time, submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) 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. E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Notices]
[Pages 44560-44561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15472]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0081]


Guidance for Industry: Adequate and Appropriate Donor Screening 
Tests for Hepatitis B; Hepatitis B Surface Antigen Assays Used to Test 
Donors of Whole Blood and Blood Components, Including Source Plasma and 
Source Leukocytes; 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: Adequate 
and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B 
Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and 
Blood Components, Including Source Plasma and Source Leukocytes'' dated 
July 2007. The guidance document provides recommendations to 
manufacturers of HBsAg assays that are intended to test donors of Whole 
Blood and blood components, including Source Plasma and Source 
Leukocytes, and to establishments using an HBsAg assay. Topics include 
recommendations on minimum sensitivity standards for HBsAg assays. This 
guidance finalizes the draft guidance entitled ``Guidance for Industry: 
A Modified Lot-Release Specification for Hepatitis B Surface Antigen 
(HBsAg) Assays Used to Test Blood, Blood Components, and Source Plasma 
Donations'' dated April 2002.

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: Joseph L. Okrasinski, Jr., 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

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Adequate and Appropriate Donor Screening Tests 
for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to 
Test Donors of Whole Blood and Blood Components, Including Source 
Plasma and Source Leukocytes'' dated July 2007. The guidance document 
provides recommendations to manufacturers of HBsAg assays that are 
approved donor screening tests intended to screen donors of Whole Blood 
and blood components, including Source Plasma and Source Leukocytes for 
Hepatitis B, and to establishments using an HBsAg assay (See Sec.  
610.40(b) (21 CFR 610.40(b)). The document represents FDA's current 
thinking on minimum sensitivity for such HBsAg assays as they relate to 
donor testing ``to reduce adequately and appropriately the risk of 
transmission of communicable disease'' under Sec.  610.40(b). Under 21 
CFR 610.44, the manufacturers of HBsAg assays used to test donations 
must verify acceptable sensitivity and specificity of such kits by 
testing the kit-lots using an FDA reference panel. This guidance 
document recommends that all HBsAg detection assays used to test donors 
of Whole Blood and blood components, including Source Plasma and Source 
Leukocytes, have a lower limit of detection standard of 0.5ng HBsAg/mL 
or less.
    In the Federal Register of April 11, 2002 (67 FR 17704), FDA 
announced the availability of the draft guidance entitled ``Guidance 
for Industry: A Modified Lot-Release Specification for Hepatitis B 
Surface Antigen (HBsAg) Assays Used to Test Blood, Blood Components, 
and Source Plasma Donations.'' FDA received a few comments on the draft 
guidance, and those comments were considered as the guidance was 
finalized. In addition, editorial changes were made to improve clarity. 
The recommended implementation date for the recommendations in this 
guidance is January 31, 2008. This guidance document finalizes the 
draft guidance document entitled ``Guidance for

[[Page 44561]]

Industry: A Modified Lot-Release Specification for Hepatitis B Surface 
Antigen (HBsAg) Assays Used to Test Blood, Blood Components, and Source 
Plasma Donations'' dated April 2002.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 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. Comments

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

III. 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: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-15472 Filed 8-7-07; 8:45 am]
BILLING CODE 4160-01-S

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