``Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;'' Availability, 37863-37864 [05-12960]

Download as PDF Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Notices 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 July 22, 2005, from 8 a.m. to 5 p.m. Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20879. Contact Person: William Freas or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. Agenda: On July 22, 2005, the subcommittee will listen to presentations to further a dynamic, responsive, and cutting edge research program at the Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), that facilitates development of safe and effective biological products. The subcommittee’s recommendations will be publicly discussed at a future meeting of the Blood Products Advisory Committee. Information regarding CBER’s scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the Internet at: http://www.fda.gov/cber/inside/ mission.htm. Information regarding FDA’s Critical Path to New Medical Products is available to the public on the Internet at: http://www.fda.gov/oc/ initiatives/criticalpath/. Procedure: On July 22, 2005, from 8 a.m. to 1:15 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person by July 14, 2005. Oral presentations from the public will be scheduled between approximately 12:15 p.m. and 1:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person by July 14, 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. Closed Subcommittee Deliberations: On July 22, 2005, from 2:15 p.m. to 5 p.m., the meeting will be closed to the public. The meeting will be closed to VerDate jul<14>2003 16:26 Jun 29, 2005 Jkt 205001 permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The subcommittee will discuss the internal research programs in the Office of Blood Research and Review, CBER. 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 William Freas or Pearline K. Muckelvene 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: June 23, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–12962 Filed 6–29–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0133] ‘‘Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;’’ 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: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection’’ dated June 2005. This guidance document provides revisions to the previously published recommendations for assessing donor suitability and product safety when donors are diagnosed with or suspected of West Nile Virus (WNV) infection based on symptoms and laboratory tests. This guidance revises recommended deferral periods for such donors, and updates information on component retrieval and quarantine. This guidance finalizes the PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 37863 draft ‘‘Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection’’ dated April 2005 and supersedes the final ‘‘Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection’’ dated May 2003. Elsewhere in this issue of the Federal Register, FDA is withdrawing the guidance entitled ‘‘Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection,’’ dated May 2005. Submit written or electronic comments on agency guidances at any time. DATES: 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, 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 http:// www.fda.gov/dockets/ecomments. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, 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: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,’’ dated June 2005. FDA developed the information in this guidance after consulting with other Public Health Service Agencies of the Department of Health and Human Services. This guidance does the following things: E:\FR\FM\30JNN1.SGM 30JNN1 37864 Federal Register / Vol. 70, No. 125 / Thursday, June 30, 2005 / Notices • Applies to donors of blood and blood components intended for transfusion; • Applies to donors of blood components intended for use in further manufacturing into injectable products or noninjectable products, including recovered plasma, Source Leukocytes, and Source Plasma; • Provides updated scientific data; • Recommends new deferral periods for donors who are diagnosed with or suspected of WNV infection; and • Describes the use of the investigational nucleic acid test (NAT) for WNV in deferring reactive donors. This guidance supersedes ‘‘Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection’’ dated May 2003, and finalizes the draft ‘‘Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection’’ dated April 2005. In the Federal Register of April 20, 2005 (70 FR 20575), FDA announced the availability of the draft guidance of the same title. FDA received several comments on the April 2005 draft guidance and those comments were considered when finalizing the guidance. A summary of changes to the guidance includes the following items: (1) Modifies recommendations on followup testing and reentry of reactive donors, (2) adds recommendations on component retrieval and quarantine for presumptive viremic donors, and (3) discusses preliminary laboratory data indicating WNV infectivity in blood cultures of NAT reactive individuals who were also seropositive for WNV antibodies. In addition, editorial changes were made to improve clarity. Elsewhere in this issue of the Federal Register, FDA is withdrawing the guidance entitled ‘‘Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection,’’ dated May 2005. The May 2005 guidance is no longer necessary because the guidance that is the subject of this notice does not contain the recommendation to defer donors based on recent fever with a headache as a symptom of WNV infection. 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 VerDate jul<14>2003 16:26 Jun 29, 2005 Jkt 205001 used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that 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 collection of information in this guidance was approved under OMB control number 0910–0338; 21 CFR 606.170(b) has been approved under OMB control number 0910–0116; and 21 CFR 606.171 has been approved under OMB control number 0910–0458. III. 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 http:/ /www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/ default.htm. Dated: June 24, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–12960 Filed 6–29–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002D–0467] ‘‘Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection’’; Withdrawal of Guidance AGENCY: Food and Drug Administration, HHS. ACTION: Notice; withdrawal. SUMMARY: The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ‘‘Guidance for Industry: Discontinuation PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection’’ (May 2005 guidance) that was issued on May 6, 2005. A guidance entitled ‘‘Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,’’ dated June 2005, is being announced elsewhere in this issue of the Federal Register, and supersedes the May 2003 guidance entitled ‘‘Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection’’ (May 2003 guidance) (68 FR 25897). DATES: June 30, 2005. FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. In a notice published in the Federal Register of May 23, 2005 (70 FR 29529), FDA announced the availability of the May 2005 guidance. This guidance removed FDA’s previous recommendation concerning deferral of donors of Whole Blood and blood components for transfusion and for further manufacturing use on the basis of a specific donor question related to West Nile Virus infection (i.e., to defer donors each year between June 1 and November 30 when the donor reports a history of fever with headache in the past week). Donor deferral based on this information was originally recommended in the May 2003 guidance. The guidance entitled ‘‘Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,’’ dated June 2005, announced elsewhere in this issue of the Federal Register, supersedes the May 2003 guidance and does not recommend donor deferral based upon a reported history of fever with headache in the week prior to donation. Therefore, the May 2005 guidance is being withdrawn because it is no longer necessary. SUPPLEMENTARY INFORMATION: Dated: June 24, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–12961 Filed 6–29–05; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\30JNN1.SGM 30JNN1

Agencies

[Federal Register Volume 70, Number 125 (Thursday, June 30, 2005)]
[Notices]
[Pages 37863-37864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0133]


``Guidance for Industry: Assessing Donor Suitability and Blood 
and Blood Product Safety in Cases of Known or Suspected West Nile Virus 
Infection;'' 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: Assessing 
Donor Suitability and Blood and Blood Product Safety in Cases of Known 
or Suspected West Nile Virus Infection'' dated June 2005. This guidance 
document provides revisions to the previously published recommendations 
for assessing donor suitability and product safety when donors are 
diagnosed with or suspected of West Nile Virus (WNV) infection based on 
symptoms and laboratory tests. This guidance revises recommended 
deferral periods for such donors, and updates information on component 
retrieval and quarantine. This guidance finalizes the draft ``Guidance 
for Industry: Assessing Donor Suitability and Blood and Blood Product 
Safety in Cases of Known or Suspected West Nile Virus Infection'' dated 
April 2005 and supersedes the final ``Guidance for Industry: Revised 
Recommendations for the Assessment of Donor Suitability and Blood and 
Blood Product Safety in Cases of Known or Suspected West Nile Virus 
Infection'' dated May 2003. Elsewhere in this issue of the Federal 
Register, FDA is withdrawing the guidance entitled ``Guidance for 
Industry: Discontinuation of Donor Deferral Related to Recent Fever 
with Headache as a Symptom of West Nile Virus Infection,'' dated May 
2005.

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, 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 http://
www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, 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: Assessing Donor Suitability and Blood and 
Blood Product Safety in Cases of Known or Suspected West Nile Virus 
Infection,'' dated June 2005. FDA developed the information in this 
guidance after consulting with other Public Health Service Agencies of 
the Department of Health and Human Services.
    This guidance does the following things:

[[Page 37864]]

     Applies to donors of blood and blood components intended 
for transfusion;
     Applies to donors of blood components intended for use in 
further manufacturing into injectable products or noninjectable 
products, including recovered plasma, Source Leukocytes, and Source 
Plasma;
     Provides updated scientific data;
     Recommends new deferral periods for donors who are 
diagnosed with or suspected of WNV infection; and
     Describes the use of the investigational nucleic acid test 
(NAT) for WNV in deferring reactive donors.
    This guidance supersedes ``Guidance for Industry: Revised 
Recommendations for the Assessment of Donor Suitability and Blood and 
Blood Product Safety in Cases of Known or Suspected West Nile Virus 
Infection'' dated May 2003, and finalizes the draft ``Guidance for 
Industry: Assessing Donor Suitability and Blood and Blood Product 
Safety in Cases of Known or Suspected West Nile Virus Infection'' dated 
April 2005.
    In the Federal Register of April 20, 2005 (70 FR 20575), FDA 
announced the availability of the draft guidance of the same title. FDA 
received several comments on the April 2005 draft guidance and those 
comments were considered when finalizing the guidance. A summary of 
changes to the guidance includes the following items: (1) Modifies 
recommendations on followup testing and reentry of reactive donors, (2) 
adds recommendations on component retrieval and quarantine for 
presumptive viremic donors, and (3) discusses preliminary laboratory 
data indicating WNV infectivity in blood cultures of NAT reactive 
individuals who were also seropositive for WNV antibodies. In addition, 
editorial changes were made to improve clarity. Elsewhere in this issue 
of the Federal Register, FDA is withdrawing the guidance entitled 
``Guidance for Industry: Discontinuation of Donor Deferral Related to 
Recent Fever with Headache as a Symptom of West Nile Virus Infection,'' 
dated May 2005. The May 2005 guidance is no longer necessary because 
the guidance that is the subject of this notice does not contain the 
recommendation to defer donors based on recent fever with a headache as 
a symptom of WNV infection.
    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 contains information collection provisions that 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 
collection of information in this guidance was approved under OMB 
control number 0910-0338; 21 CFR 606.170(b) has been approved under OMB 
control number 0910-0116; and 21 CFR 606.171 has been approved under 
OMB control number 0910-0458.

III. 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 http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/
ohrms/dockets/default.htm.

    Dated: June 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12960 Filed 6-29-05; 8:45 am]
BILLING CODE 4160-01-S