``Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection;'' Availability, 29529-29530 [05-10222]

Download as PDF Federal Register / Vol. 70, No. 98 / Monday, May 23, 2005 / Notices before the committee. Written submissions may be made to the contact person by July 8, 2005. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. on July 13 and 14, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 8, 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 Marcia Moore 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: May 16, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–10251 Filed 5–20–05; 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;’’ 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: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection,’’ dated May 2005. The guidance document removes FDA’s previous recommendation concerning deferral on the basis of a specific donor question related to West Nile Virus (WNV) infection. This VerDate jul<14>2003 16:20 May 20, 2005 Jkt 205001 guidance pertains solely to this specific donor deferral recommendation; all other recommendations in the ‘‘Guidance for Industry: 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 remain in effect. This guidance applies to Whole Blood and blood components intended for transfusion, and blood components intended for use in further manufacturing into injectable products or noninjectable products, including recovered plasma, Source Leukocytes and Source Plasma. This guidance has an immediate implementation date due to the approaching season during which an outbreak of WNV can occur. 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 the CBER Voice Information System 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: Astrid Szeto, 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: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection,’’ dated May 2005. The guidance document removes FDA’s previous recommendation 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. We no longer recommend PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 29529 asking this question as it relates to WNV. This donor deferral was originally recommended in the ‘‘Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection.’’ Since the issuance of this May 2003 guidance, new data were presented at the October 22, 2004, Blood Products Advisory Committee Meeting indicating that self-reported fever with headache in the past week did not appear to be predictive of WNV infection and did not correlate with peak periods of WNV incidence as determined by WNV nucleic acid test prevalence in the donor pool. 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. 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 information collection provisions in this guidance for 21 CFR 601.12 have been approved under OMB control number 0910–0338. III. Comments FDA is soliciting public comment, but is implementing this guidance immediately because the agency has determined that prior public participation is not feasible or appropriate. This is because blood establishments need to establish suitable standard operating procedures as soon as possible in preparation for the approaching season during which an outbreak of WNV can occur. 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 E:\FR\FM\23MYN1.SGM 23MYN1 29530 Federal Register / Vol. 70, No. 98 / Monday, May 23, 2005 / Notices 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 https://www.fda.gov/ohrms/dockets/ default.htm. Dated: May 16, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–10222 Filed 5–20–05; 8:45 am] BILLING CODE 4160–01–S Dated: May 17, 2005. George Frederick McCray, Chief, Intellectual Property Rights Branch. [FR Doc. 05–10185 Filed 5–20–05; 8:45 am] BILLING CODE 4820–02–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR–4971–N–26] Notice of Submission of Proposed Information Collection to OMB; Application for Relocation Assistance Office of the Chief Information Officer, HUD. ACTION: Notice. AGENCY: DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection [CBP Decision 05–20] Recordation of Trade Name: ‘‘Precision Instrument Manifolds’’ Department of Home Security, U.S. Customs and Border Protection (CPB), Office of Regulations & Rulings, Intellectual Property Rights Branch. ACTION: Notice of recordation. AGENCY: SUMMARY: On December 15, 2004, a notice of application for the recordation under section 42 of the Act of July 5, 1946, as amended (15 U.S.C. 1124), of the trade name ‘‘Precision Instrument Manifolds’’, was published in the Federal Register (69 FR 75078 and 75079). The notice advised that before final action was taken on the application, consideration would be given to any relevant data, views, or arguments submitted in writing by any person in opposition to the recordation and received not later than February 14, 2005. No responses were received in opposition to the notice. Accordingly, as provided in section 133.14, Customs Regulations (19 CFR 133.14), the name ‘‘Precision Instrument Manifolds,’’ is recorded as the trade name used by Dynamic Controls & Sensors, Inc., a corporation organized under the laws of Texas, located at P.O. Box 5009 Kingwood, Texas. The trade name is used in connection with valves. EFFECTIVE DATE: May 23, 2005. FOR FURTHER INFORMATION CONTACT: Delois P. Johnson, Paralegal, Intellectual Property Rights Branch, 1300 Pennsylvania Avenue, NW., (Mint Annex), Washington, DC 20229 (202 572–8703). VerDate jul<14>2003 16:20 May 20, 2005 Jkt 205001 SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Application for displacement/ relocation assistance for person (families, individuals, businesses, nonprofit organization and farms) displaced by certain HUD programs. Periodically, HUD reviews a random sample of the Agency files to assure that persons did receive the relocation payments to which they are entitled. This information collection incorporates revised, government-wide regulations. DATES: Comments Due Date: June 22, 2005. Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2506–0016) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Wayne Eddins, Reports Management Officer, AYO, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; email Wayne_Eddins@HUD.gov; or Lillian Deitzer at Lillian_L_Deitzer@HUD.gov or telephone (202) 708–2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Mr. Eddins or Ms. Deitzer. ADDRESSES: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information SUPPLEMENTARY INFORMATION: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: Title of Proposal: Application for Relocation Assistance. OMB Approval Number: 2506–0016. Form Numbers: HUD–40054, HUD– 40055, HUD–40056, HUD–40057, HUD– 40058, HUD–40061, HUD–40072. Description Of The Need For The Information And Its Proposed Use: Application for displacement/relocation assistance for person (families, individuals, businesses, nonprofit organization and farms) displaced by certain HUD programs. Periodically, HUD reviews a random sample of housing agency files to assure that persons did receive the relocation payments to which they are entitled. Revised government-wide URA regulations were published by the Department of Transportation on January 4, 2005 (effective February 3, 2005). Changes in these regulations which will impact on HUD forms are: Including the cost of professional home inspections in replacement housing payments for homeowners (24.401(e)(4)), and implementing the use of HUD low income limits to determine eligibility for URA benefits applicable to low income persons (24.402(b)(2)). Only the HUD–40054 and 40058 will be affected by these changes and will be revised to conform to the new regulations and improve the flow of the form. The HUD–40055, 40056, and 40057 will be revised to more closely track the existing regulations and improve the flow of the forms. A minor change is being made to the HUD–40061 to eliminate the requirement that the agency make adjustments to the asking price for a property to reflect an anticipated sale price (this requirement was eliminated in the new rule). No E:\FR\FM\23MYN1.SGM 23MYN1

Agencies

[Federal Register Volume 70, Number 98 (Monday, May 23, 2005)]
[Notices]
[Pages 29529-29530]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10222]


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

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;'' 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: 
Discontinuation of Donor Deferral Related to Recent Fever with Headache 
as a Symptom of West Nile Virus Infection,'' dated May 2005. The 
guidance document removes FDA's previous recommendation concerning 
deferral on the basis of a specific donor question related to West Nile 
Virus (WNV) infection. This guidance pertains solely to this specific 
donor deferral recommendation; all other recommendations in the 
``Guidance for Industry: 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 remain in effect. 
This guidance applies to Whole Blood and blood components intended for 
transfusion, and blood components intended for use in further 
manufacturing into injectable products or noninjectable products, 
including recovered plasma, Source Leukocytes and Source Plasma. This 
guidance has an immediate implementation date due to the approaching 
season during which an outbreak of WNV can occur.

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 the CBER Voice Information System 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: Astrid Szeto, 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: Discontinuation of Donor Deferral Related to 
Recent Fever with Headache as a Symptom of West Nile Virus Infection,'' 
dated May 2005. The guidance document removes FDA's previous 
recommendation 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. We no longer recommend asking this question as it relates to WNV. 
This donor deferral was originally recommended in the ``Guidance for 
Industry: Recommendations for the Assessment of Donor Suitability and 
Blood and Blood Product Safety in Cases of Known or Suspected West Nile 
Virus Infection.'' Since the issuance of this May 2003 guidance, new 
data were presented at the October 22, 2004, Blood Products Advisory 
Committee Meeting indicating that self-reported fever with headache in 
the past week did not appear to be predictive of WNV infection and did 
not correlate with peak periods of WNV incidence as determined by WNV 
nucleic acid test prevalence in the donor pool.
    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.

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 
information collection provisions in this guidance for 21 CFR 601.12 
have been approved under OMB control number 0910-0338.

III. Comments

    FDA is soliciting public comment, but is implementing this guidance 
immediately because the agency has determined that prior public 
participation is not feasible or appropriate. This is because blood 
establishments need to establish suitable standard operating procedures 
as soon as possible in preparation for the approaching season during 
which an outbreak of WNV can occur. 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

[[Page 29530]]

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.

    Dated: May 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-10222 Filed 5-20-05; 8:45 am]
BILLING CODE 4160-01-S

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