Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); Availability, 29519-29520 [E8-11433]

Download as PDF 29519 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Notices Estimated Total Annual Burden Hours: 1,743. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: May 14, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–11188 Filed 5–20–08; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [OMB No.: 0970–0177] Submission for OMB Review; Comment Request Title: OCSE–157 Child Support Enforcement Program Annual Data Report. Description: The information obtained from this form will be used to: (1) Report Child Support Enforcement activities to the Congress as required by law; (2) calculate incentive measures performance and performance indicators utilized in the program; and (3) assist the Office of Child Support Enforcement in monitoring and evaluating State Child Support programs. Respondents: State, Local or Tribal Government. ANNUAL BURDEN ESTIMATES Number of respondents Number of responses per respondent Average burden hours per response Total burden hours OCSE–157 ....................................................................................................... cprice-sewell on PROD1PC69 with NOTICES Instrument 54 1 7 378.0 Estimated Total Annual Burden Hours: 378.0 Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 378.0 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: May 14, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–11190 Filed 5–20–08; 8:45 am] BILLING CODE 4184–01–M VerDate Aug<31>2005 15:18 May 20, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0263] Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); 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: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)’’ dated May 2008. The draft guidance document provides recommendations to establishments that collect human blood or blood components for a requalification method or process to reenter deferred donors into a donor pool based on a determination that the previous tests that were repeatedly reactive for anti- PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 HBc were falsely positive and that there is no evidence of infection with Hepatitis B virus (HBV). 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 written or electronic comments on the draft guidance by August 19, 2008. DATES: 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 ADDRESSES: E:\FR\FM\21MYN1.SGM 21MYN1 29520 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Notices electronic comments to http:// www.regulations.gov. Paul E. 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: FOR FURTHER INFORMATION CONTACT: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)’’ dated May 2008. FDA is providing recommendations to establishments that collect human blood or blood components for a requalification method or process for the reentry of deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for anti-HBc were falsely positive and that there is no evidence of infection with HBV. Due to the availability of this licensed HBV nucleic acid test and the improved specificity of anti-HBc assays, we are recommending a reentry algorithm for donors deferred due to a falsely positive repeatedly reactive test for anti-HBc in this guidance. Until now FDA has not recommended a requalification method or process for reentry of donors deferred due to reactive test results for hepatitis B core antigen (anti-HBc) due to the lack of licensed tests that could be recommended for use in a suitable algorithm for this purpose. 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. cprice-sewell on PROD1PC69 with NOTICES 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 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 VerDate Aug<31>2005 15:18 May 20, 2008 Jkt 214001 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. The petition proposes to amend the food additive regulations in part 172, Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172) to provide for the safe use of cassia gum as a stabilizer in frozen dairy desserts, and to improve texture and water retention in cheeses, meat products, and poultry products. The agency has determined under 21 CFR 25.32(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Electronic Access Dated: May 13, 2008. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E8–11279 Filed 5–20–08; 8:45 am] Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/cber/guidelines.htm or http://www.regulations.gov. Dated: May 12, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–11433 Filed 5–20–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S Indian Health Service DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Loan Repayment Program Food and Drug Administration AGENCY: [Docket No. FDA–2008–F–0290] ACTION: Lubrizol Advanced Materials, Inc.; Filing of Food Additive Petition SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917– 0014, ‘‘Indian Health Service Loan Repayment Program.’’ Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917– 0014, ‘‘Indian Health Service Loan Repayment Program.’’ Form(s): The IHS Loan Repayment Program Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that Lubrizol Advanced Materials, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of cassia gum as a stabilizer in frozen dairy desserts, and to improve texture and water retention in cheeses, meat products, and poultry products. FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740– 3835, 301–436–1272. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 8A4772) has been filed by Lubrizol Advanced Materials, Inc., c/o Keller & Heckman LLP, 1001 G St., NW., suite 500 West, Washington, DC 20001. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM Indian Health Service, HHS. Notice. 21MYN1

Agencies

[Federal Register Volume 73, Number 99 (Wednesday, May 21, 2008)]
[Notices]
[Pages 29519-29520]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11433]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0263]


Draft Guidance for Industry: Requalification Method for Reentry 
of Blood Donors Deferred Because of Reactive Test Results for Antibody 
to Hepatitis B Core Antigen (Anti-HBc); 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: 
Requalification Method for Reentry of Blood Donors Deferred Because of 
Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-
HBc)'' dated May 2008. The draft guidance document provides 
recommendations to establishments that collect human blood or blood 
components for a requalification method or process to reenter deferred 
donors into a donor pool based on a determination that the previous 
tests that were repeatedly reactive for anti-HBc were falsely positive 
and that there is no evidence of infection with Hepatitis B virus 
(HBV).

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 written or electronic comments on the draft guidance 
by August 19, 2008.

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

[[Page 29520]]

electronic comments to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Paul E. 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: Requalification Method for Reentry of Blood 
Donors Deferred Because of Reactive Test Results for Antibody to 
Hepatitis B Core Antigen (Anti-HBc)'' dated May 2008. FDA is providing 
recommendations to establishments that collect human blood or blood 
components for a requalification method or process for the reentry of 
deferred donors into the donor pool based on a determination that 
previous tests that were repeatedly reactive for anti-HBc were falsely 
positive and that there is no evidence of infection with HBV. Due to 
the availability of this licensed HBV nucleic acid test and the 
improved specificity of anti-HBc assays, we are recommending a reentry 
algorithm for donors deferred due to a falsely positive repeatedly 
reactive test for anti-HBc in this guidance. Until now FDA has not 
recommended a requalification method or process for reentry of donors 
deferred due to reactive test results for hepatitis B core antigen 
(anti-HBc) due to the lack of licensed tests that could be recommended 
for use in a suitable algorithm for this purpose.
    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 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: May 12, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-11433 Filed 5-20-08; 8:45 am]
BILLING CODE 4160-01-S