Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability, 72951-72952 [2011-30552]

Download as PDF Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Notices pmangrum on DSK3VPTVN1PROD with NOTICES collect Whole Blood and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes. The draft guidance, when finalized, is intended to supplement previous memoranda and guidance from FDA concerning the testing of donations for hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc), and the management of donors and units mentioned in those documents. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 27, 2012. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401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 The draft guidance may also be obtained by mail by calling CBER at 1–(800) 835– 4709 or (301) 827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Paul Levine, 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 draft document entitled ‘‘Guidance for Industry: Use of Nucleic Acid Tests (NAT) on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Recovered Plasma, Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of Hepatitis B Virus (HBV), and Requalification of Donors Who Test HBV NAT Positive,’’ dated November 2011. FDA is providing blood establishments that collect Whole Blood VerDate Mar<15>2010 15:34 Nov 25, 2011 Jkt 226001 and blood components for transfusion or for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes; with recommendations concerning the use of FDA-licensed NAT to screen blood donors for HBV DNA. FDA is also providing these blood establishments with recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. In addition, FDA is notifying those blood establishments that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. FDA-licensed HBV NAT can detect evidence of infection at an earlier stage than is possible using previously approved HBsAg and anti-HBc tests. Therefore, FDA is recommending the use of an FDA-licensed HBV NAT, in accordance with the requirements under 610.40(a) and (b) (21 CFR 610.40(a) and (b)). The draft guidance, when finalized, is intended to supplement previous memoranda and guidance from FDA to blood establishments concerning the testing of donations for HBsAg and antiHBc, and the management of donors and units mentioned in those documents. Note that testing Whole Blood and blood components for transfusion and Source Leukocytes for further manufacture for HBsAg and anti-HBc, and Source Plasma for HBsAg should continue when a blood establishment implements HBV NAT. FDA may consider advancements in technology for testing blood donations, as well as data obtained following the implementation of HBV NAT, to make future recommendations on adequate and appropriate testing for HBV. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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 requirement of the applicable statutes and regulations. II. 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 collections of information in 606.121, 610.40 and PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 72951 640.70 have been approved under OMB Control Numbers 0910–0537, 0910– 0116, and 0910–0338, respectively. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/ BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: November 21, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–30449 Filed 11–25–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0386] Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.’’ This guidance document provides industry and Agency staff with recommendations for studies to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the SUMMARY: E:\FR\FM\28NON1.SGM 28NON1 72952 Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Notices pmangrum on DSK3VPTVN1PROD with NOTICES detection, or detection and differentiation, of human papillomaviruses. DATES: Submit either electronic or written 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 ‘‘Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to (301) 847–8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Kate Simon, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5552, Silver Spring, MD 20993–0002, (301) 796–6210. SUPPLEMENTARY INFORMATION: I. Background FDA is issuing this guidance to provide industry and Agency staff with recommendations for studies to establish the performance characteristics of IVDs intended for the detection, or detection and differentiation, of human papillomaviruses. These devices are used in conjunction with cervical cytology to aid in screening for cervical cancer. They include devices that detect a group of human papillomavirus (HPV) genotypes, particularly high risk human papillomaviruses, as well as devices that detect more than one genotype of HPV and further differentiate among them to indicate which genotype(s) of HPV is (are) present. In the Federal Register of September 9, 2009 (74 FR 46433), FDA announced the availability of the draft guidance. Comments on the draft guidance were due by December 8, 2009. Five VerDate Mar<15>2010 15:34 Nov 25, 2011 Jkt 226001 comments were received on the guidance document. We reviewed the comments and took their suggestions into consideration in revising this guidance. II. Significance of Guidance This 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 establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses. 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. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to (301) 847–8149 to receive a hard copy. Please use the document number 1740 to identify the guidance you are requesting. 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 814 have been approved under OMB control number. 0910–0231; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910–0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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: November 22, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–30552 Filed 11–25–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–D–0086 (formerly Docket No. 2005D–0223)] Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.’’ The purpose of this guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation effects (radiation-induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late-occurring irreversible radiation toxicities in clinical trials of therapeutic radiopharmaceuticals. This guidance finalizes the draft guidance of the same name issued in June 2005. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY SUMMARY: E:\FR\FM\28NON1.SGM 28NON1

Agencies

[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72951-72952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30552]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0386]


Guidance for Industry and Food and Drug Administration Staff; 
Establishing the Performance Characteristics of In Vitro Diagnostic 
Devices for the Detection or Detection and Differentiation of Human 
Papillomaviruses; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Establishing the Performance 
Characteristics of In Vitro Diagnostic Devices for the Detection or 
Detection and Differentiation of Human Papillomaviruses.'' This 
guidance document provides industry and Agency staff with 
recommendations for studies to establish the performance 
characteristics of in vitro diagnostic devices (IVDs) intended for the

[[Page 72952]]

detection, or detection and differentiation, of human papillomaviruses.

DATES: Submit either electronic or written 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 ``Establishing the Performance Characteristics of In 
Vitro Diagnostic Devices for the Detection or Detection and 
Differentiation of Human Papillomaviruses'' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to (301) 847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kate Simon, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5552, Silver Spring, MD 20993-0002, (301) 796-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to provide industry and Agency staff 
with recommendations for studies to establish the performance 
characteristics of IVDs intended for the detection, or detection and 
differentiation, of human papillomaviruses. These devices are used in 
conjunction with cervical cytology to aid in screening for cervical 
cancer. They include devices that detect a group of human 
papillomavirus (HPV) genotypes, particularly high risk human 
papillomaviruses, as well as devices that detect more than one genotype 
of HPV and further differentiate among them to indicate which 
genotype(s) of HPV is (are) present.
    In the Federal Register of September 9, 2009 (74 FR 46433), FDA 
announced the availability of the draft guidance. Comments on the draft 
guidance were due by December 8, 2009. Five comments were received on 
the guidance document. We reviewed the comments and took their 
suggestions into consideration in revising this guidance.

II. Significance of Guidance

    This 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 establishing the performance 
characteristics of in vitro diagnostic devices for the detection or 
detection and differentiation of human papillomaviruses. 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. A search capability for all CDRH guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. To receive 
``Establishing the Performance Characteristics of In Vitro Diagnostic 
Devices for the Detection or Detection and Differentiation of Human 
Papillomaviruses,'' you may either send an email request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to (301) 847-8149 to receive a hard copy. Please use 
the document number 1740 to identify the guidance you are requesting.

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 814 have been approved under 
OMB control number. 0910-0231; the collections of information in 21 CFR 
part 812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 801 and 21 CFR 809.10 have 
been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-30552 Filed 11-25-11; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.