Draft Guidance for Industry on Nucleic Acid Testing for Human Immunodeficiency Virus Type 1 and Hepatitis C Virus: Testing, Product Disposition, and Donor Deferral and Reentry; Availability, 43439-43440 [05-14746]

Download as PDF Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices Dated: July 20, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–14750 Filed 7–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on August 25 and 26, 2005, from 8 a.m. to 6 p.m on both days. Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: David Krause, Center for Devices and Radiological Health (HFZ–410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301–594–3090, ext. 141, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512519. Please call the Information Line for up-to-date information on this meeting. Agenda: On August 25, 2005, the committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of five preamendments medical devices: Bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug. Background information for this meeting, including the agenda and questions for the committee, will be made available at least 1 business day before the meeting VerDate jul<14>2003 19:40 Jul 26, 2005 Jkt 205001 on the Internet at http://www.fda.gov/ cdrh/panelmtg.html. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by August 11, 2005. On August 25, 2005, oral presentations from the public will be scheduled between approximately 10:15 a.m. and 10:45 a.m., 1:45 p.m. and 2:15 p.m., and 4:30 p.m. and 5 p.m. On August 26, 2005, oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m., 1 p.m. and 1:30 p.m., and 3:45 p.m. and 4:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before 5 p.m. on August 11, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams at 240–276–0450, ext. 113, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 20, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–14749 Filed 7–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0261] Draft Guidance for Industry on Nucleic Acid Testing for Human Immunodeficiency Virus Type 1 and Hepatitis C Virus: Testing, Product Disposition, and Donor Deferral and Reentry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00050 Fmt 4703 Sfmt 4703 43439 SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV– 1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry,’’ dated July 2005. The draft guidance document provides information for blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for NAT on pooled or individual samples of human blood and blood component donations for HIV–1 ribonucleic acid (RNA) and HCV RNA. The draft guidance document is intended to encourage more effective testing of whole blood and blood component samples, and improved product and donor management based on the results of NAT and concurrent serologic testing for markers of HIV and HCV infection on donated whole blood and blood components. DATES: Submit written or electronic comments on the draft guidance by October 25, 2005 to ensure their adequate consideration in preparation of the final guidance. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft 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 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 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 http:// 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 draft document entitled ‘‘Guidance for E:\FR\FM\27JYN1.SGM 27JYN1 43440 Federal Register / Vol. 70, No. 143 / Wednesday, July 27, 2005 / Notices Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV–1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry’’ dated July 2005. There has been a dramatic reduction during the past decade in the transmission of HIV–1 and HCV by human blood and blood components. The reduction is a result of the implementation of sensitive tests for viral antibody, antigen (for HIV–1), and nucleic acids, and the use of effective virus removal and inactivation methods. The sources of remaining risk of HIV– 1 and HCV transmission are markernegative ‘‘window period’’ donations, donors infected with immunovariant viral strains, persistent antibodynegative (immunosilent) carriers, and laboratory test procedure errors. Because donations during the window period constitute most of the risk of HIV–1 and HCV transmission, measures to close the ‘‘window period’’ further could reduce significantly the low residual risk of HIV–1 and HCV transmission by human blood and blood components. Studies using seroconversion panels indicate the value of NAT in reducing the ‘‘window period’’ for HIV–1 and HCV. 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. 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) written or electronic comments regarding the draft guidance. Submit written or electronic comments to ensure adequate consideration in preparation of the final 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 draft 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. VerDate jul<14>2003 19:40 Jul 26, 2005 Jkt 205001 III. Electronic Access Persons with access to the Internet may obtain the guidance at either http:/ /www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/ default.htm. Dated: July 19, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–14746 Filed 7–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ADDERALL XR (mixed salts of a single-entity amphetamine product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron). These summaries are being made available consistent with section 9 of the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. ADDRESSES: Submit written requests for single copies of the summaries to the Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please specify by product name which summary or summaries you are requesting. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries. FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research (HFD–960), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594–7337, e-mail: carmouzeg@cder.fda.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for ADDERALL XR (mixed salts of a single-entity amphetamine product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron). The summaries are being made available consistent with section 9 of the BPCA (Public Law 107–109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the pediatric exclusivity program described in section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a). Section 505A of the act, permits certain applications to obtain 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. One of the provisions the BPCA added to the pediatric exclusivity program pertains to the dissemination of pediatric information. Specifically, for all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are to be made available not later than 180 days after the report on the pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision of the BPCA, FDA has posted on the Internet at http://www.fda.gov/ cder/pediatric/index.htm, summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ADDERALL XR (mixed salts of a single-entity amphetamine product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron). Copies are also available by mail (see ADDRESSES). II. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/cder/pediatric/index.htm. Dated: July 20, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–14747 Filed 7–26–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\27JYN1.SGM 27JYN1

Agencies

[Federal Register Volume 70, Number 143 (Wednesday, July 27, 2005)]
[Notices]
[Pages 43439-43440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14746]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0261]


Draft Guidance for Industry on Nucleic Acid Testing for Human 
Immunodeficiency Virus Type 1 and Hepatitis C Virus: Testing, Product 
Disposition, and Donor Deferral and Reentry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 
(HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and 
Donor Deferral and Reentry,'' dated July 2005. The draft guidance 
document provides information for blood and plasma establishments, 
manufacturers, and testing laboratories that are implementing a 
licensed method for NAT on pooled or individual samples of human blood 
and blood component donations for HIV-1 ribonucleic acid (RNA) and HCV 
RNA. The draft guidance document is intended to encourage more 
effective testing of whole blood and blood component samples, and 
improved product and donor management based on the results of NAT and 
concurrent serologic testing for markers of HIV and HCV infection on 
donated whole blood and blood components.

DATES: Submit written or electronic comments on the draft guidance by 
October 25, 2005 to ensure their adequate consideration in preparation 
of the final guidance. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
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 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 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 http://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 draft document entitled 
``Guidance for

[[Page 43440]]

Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus 
Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product 
Disposition, and Donor Deferral and Reentry'' dated July 2005. There 
has been a dramatic reduction during the past decade in the 
transmission of HIV-1 and HCV by human blood and blood components. The 
reduction is a result of the implementation of sensitive tests for 
viral antibody, antigen (for HIV-1), and nucleic acids, and the use of 
effective virus removal and inactivation methods. The sources of 
remaining risk of HIV-1 and HCV transmission are marker-negative 
``window period'' donations, donors infected with immunovariant viral 
strains, persistent antibody-negative (immunosilent) carriers, and 
laboratory test procedure errors. Because donations during the window 
period constitute most of the risk of HIV-1 and HCV transmission, 
measures to close the ``window period'' further could reduce 
significantly the low residual risk of HIV-1 and HCV transmission by 
human blood and blood components. Studies using seroconversion panels 
indicate the value of NAT in reducing the ``window period'' for HIV-1 
and HCV.
    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. 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) 
written or electronic comments regarding the draft guidance. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final 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 draft 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 http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/
ohrms/dockets/default.htm.

    Dated: July 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14746 Filed 7-26-05; 8:45 am]
BILLING CODE 4160-01-S