Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing; Public Workshop; Request for Comments, 6284 [E6-1588]

Download as PDF 6284 Federal Register / Vol. 71, No. 25 / Tuesday, February 7, 2006 / Notices health. FDA said that the proposed changes would be an important step toward global harmonization of safety reporting requirements and additional efforts are underway within the Department of Health and Human Services to harmonize the reporting requirements of U.S. Federal agencies (e.g., FDA and the National Institutes of Health are continuing to work together to address the best ways to streamline information sharing and to harmonize, to the extent possible, the safety reporting requirements of the two agencies). Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–1587 Filed 2–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0045] Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. erjones on PROD1PC68 with NOTICES ACTION: The Food and Drug Administration (FDA) is announcing a public workshop entitled ‘‘Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing (NAT).’’ The purpose of the public workshop is to address regulatory and scientific challenges and opportunities in the development of policy concerning protection of the blood supply from transfusiontransmissible diseases by deferring blood donors based on high-risk behavior, and to request comments on this topic. Date and Time: The public workshop will be held on March 8, 2006, from 8 a.m. to 5:30 p.m. The deadline for registration via mail, fax, or e-mail is February 17, 2006 (see Registration). Written or electronic comments will be accepted until May 8, 2006 (see Comments). Addresses: The public workshop will be held at the National Institutes of Health, Lister Hill Auditorium, Bldg. 38A, 8600 Rockville Pike, Bethesda, MD 20894. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, VerDate Aug<31>2005 15:23 Feb 06, 2006 Jkt 208001 MD 20852. Submit electronic comments to https://www.fda.gov/dockets/ ecomments. Contact Person: Rhonda Dawson, Center for Biologics Evaluation and Research (HFM–302), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852–1448, 301–827– 6129, FAX: 301–827–2843, e-mail: Rhonda.Dawson@fda.hhs.gov. Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, and telephone and fax numbers) to Rhonda Dawson (see Contact Person) by February 17, 2006. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space-available basis beginning at 7:15 a.m. If you need special accommodations due to a disability, please contact Rhonda Dawson (see Contact Person) at least 7 days in advance. Comments: Regardless of attendance at the public workshop, interested persons may submit to the Division of Dockets Management (see Addresses) written or electronic comments regarding the public workshop. Submit electronic comments to https:// www.fda.gov/dockets/ecomments. 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. SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to address regulatory and scientific challenges and opportunities in the development of policy concerning protection of the blood supply from transfusion-transmissible diseases by deferring blood donors based on highrisk behavior. The public workshop will feature presentations by national and international experts from government and academic institutions and industry. The following discussions will be included: • Current practices in the United States and in foreign countries regarding blood donor deferrals based on high-risk behavior, • Comparison of selected tissue donor deferral policies to blood donor deferral policies, • Behavioral risks for transfusiontransmitted diseases, • Residual risks of infection from transfusion, and PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 • Potential alternative approaches to donor screening and testing. Transcripts: Transcripts of the public workshop may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. A transcript of the public workshop will be available on the Internet at https://www.fda.gov/cber/ minutes/workshop-min.htm. Dated: January 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–1588 Filed 2–6–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Independent Evaluation of the Food and Drug Administration’s First Cycle Review Performance—Retrospective Analysis Final Report; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a report entitled ‘‘Independent Evaluation of FDA’s First Cycle Review Performance— Retrospective Analysis Final Report.’’ This report describes an independent evaluation of the issues associated with FDA’s conduct of first cycle reviews of new molecular entities for new drug applications (NMEs for NDAs), and biological license applications (BLAs). Applications covered by the report are those submitted to FDA in fiscal years 2002 to 2004. This independent study was conducted in relation to the Prescription Drug User Fee Amendments of 2002 (PDUFA III). This assessment includes a detailed evaluation of the events that occurred during the review process with a focus on identifying the best practices by FDA and industry that facilitated that process. Submit written requests for single copies of this report to the Office of Planning (HFP–10), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit electronic requests to Carolyn.Staples@fda.hhs.gov. This ADDRESSES: E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 71, Number 25 (Tuesday, February 7, 2006)]
[Notices]
[Page 6284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1588]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0045]


Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid 
Testing; Public Workshop; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Behavior-Based Blood Donor Deferrals in the Era of 
Nucleic Acid Testing (NAT).'' The purpose of the public workshop is to 
address regulatory and scientific challenges and opportunities in the 
development of policy concerning protection of the blood supply from 
transfusion-transmissible diseases by deferring blood donors based on 
high-risk behavior, and to request comments on this topic.
    Date and Time: The public workshop will be held on March 8, 2006, 
from 8 a.m. to 5:30 p.m. The deadline for registration via mail, fax, 
or e-mail is February 17, 2006 (see Registration). Written or 
electronic comments will be accepted until May 8, 2006 (see Comments).
    Addresses: The public workshop will be held at the National 
Institutes of Health, Lister Hill Auditorium, Bldg. 38A, 8600 Rockville 
Pike, Bethesda, MD 20894. Submit written comments 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.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, e-mail: 
Rhonda.Dawson@fda.hhs.gov.
    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, and telephone and fax 
numbers) to Rhonda Dawson (see Contact Person) by February 17, 2006. 
There is no registration fee for the public workshop. Early 
registration is recommended because seating is limited. Registration on 
the day of the public workshop will be provided on a space-available 
basis beginning at 7:15 a.m.
    If you need special accommodations due to a disability, please 
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
    Comments: Regardless of attendance at the public workshop, 
interested persons may submit to the Division of Dockets Management 
(see Addresses) written or electronic comments regarding the public 
workshop. Submit electronic comments to https://www.fda.gov/dockets/
ecomments. 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.

SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to 
address regulatory and scientific challenges and opportunities in the 
development of policy concerning protection of the blood supply from 
transfusion-transmissible diseases by deferring blood donors based on 
high-risk behavior. The public workshop will feature presentations by 
national and international experts from government and academic 
institutions and industry. The following discussions will be included:
     Current practices in the United States and in foreign 
countries regarding blood donor deferrals based on high-risk behavior,
     Comparison of selected tissue donor deferral policies to 
blood donor deferral policies,
     Behavioral risks for transfusion-transmitted diseases,
     Residual risks of infection from transfusion, and
     Potential alternative approaches to donor screening and 
testing.
    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A transcript of the public workshop will be available 
on the Internet at https://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: January 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1588 Filed 2-6-06; 8:45 am]
BILLING CODE 4160-01-S

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