Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests; Availability, 3149-3150 [E7-978]

Download as PDF 3149 Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Notices Reduction Project, Attn: Desk Officer for ACF, Fax: 202–395–6974. Dated: January 18, 2007. Robert Sargis, Reports Clearance Officer. [FR Doc. 07–272 Filed 1–23–07; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Annual Maintenance-of-Effort (MOE) Report. OMB No. 0970–0248. Description: The Administration for Children and Families (ACF) is requesting a three-year extension of the ACF–204 (Annual MOE Report). The report is used to collect descriptive program characteristics information on the programs operated by States and Territories in association with their Temporary Assistance for Needy Families (TANF) programs. All State and Territory expenditures claimed toward States’ and Territories’ MOE requirements must be appropriate, i.e., meet all applicable MOE requirements. The Annual MOE Report provides the ability to learn about and to monitor the nature of State and Territory expenditures used to meet State’s and Territories’ MOE requirements, and it is an important source of information about the different ways that States and Territories are using their resources to help families attain and maintain selfsufficiency. In addition, the report is used to obtain State and Territory program characteristics for ACF’s annual report to Congress, and the report serves as a useful resource to use in Congressional hearings about how TANF programs are evolving, in assessing State the Territory MOE expenditures, and in assessing the need for legislative changes. Respondents: The 50 States of the United States, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands. ANNUAL BURDEN ESTIMATES Number of respondents Instrument ACF–204 .......................................................................................................... Number of responses per respondent 6,912 Estimated Total Annual Burden Hours: ........................................................................................................................................ 6,912 Dated: September 18, 2007. Robert Sargis, Reports Clearance Officer. [FR Doc. 07–273 Filed 1–23–07; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration pwalker on PROD1PC71 with NOTICES [Docket No. 2007D–0017] Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests; Availability AGENCY: Food and Drug Administration, HHS. VerDate Aug<31>2005 17:44 Jan 23, 2007 Jkt 211001 ACTION: Notice. Submit written or electronic comments on agency guidances at any time. DATES: Frm 00043 Fmt 4703 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 (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 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 https:// www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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: ADDRESSES: SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a document entitled ‘‘Guidance for Industry: Certain Human Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps) Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests’’ dated January 2007. The guidance document provides establishments that make HCT/ P donor eligibility determinations with recommendations concerning the donor eligibility requirements contained in 21 CFR part 1271, subpart C, which became effective on May 25, 2005. The guidance applies only to certain HCT/Ps that were not regulated as HCT/Ps before May 25, 2005, and that were recovered from donors beginning on or after the May 25, 2005, and within 30 days of the date of publication of this document in the Federal Register. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate. In certain cases, donor retesting needs to be initiated quickly, and the availability of certain HCT/Ps may be critical to their intended recipients. PO 00000 1 Total burden hours 128 OMB Comment: OMB 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 effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Attn: Desk Officer for ACF, Fax: 202–395–6974. 54 Average burden hours per response Sfmt 4703 I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who E:\FR\FM\24JAN1.SGM 24JAN1 3150 Federal Register / Vol. 72, No. 15 / Wednesday, January 24, 2007 / Notices Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests’’ dated January 2007. The guidance document provides establishments that make HCT/P donor eligibility determinations with recommendations concerning the donor eligibility requirements under part 1271 (21 CFR part 1271), subpart C, when donors of certain HCT/Ps were tested for communicable diseases using pooled specimens or diagnostic tests. The effective date of the regulations contained in part 1271, subpart C, was May 25, 2005 (69 FR 29785, May 25, 2004). The guidance is applicable to certain HCT/Ps that were not regulated as HCT/Ps before May 25, 2005, and that were recovered from donors on or after May 25, 2005, and within 30 days of the date of publication of this document in the Federal Register. FDA has determined that donor retesting, in certain cases, needs to be conducted in a timely manner in order to be feasible, and the availability of certain HCT/Ps may be critical to their intended recipients. The guidance is being issued consistent with FDA’s good guidance practices regulation § 10.115 (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. pwalker on PROD1PC71 with NOTICES II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information 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 collections of information in part 1271, subpart C, have been approved under OMB control number 0910–0543; the collections of information in part 1271, subpart D, and Form FDA–3486 have been approved under OMB control number 0910–0559. III. Comments FDA is soliciting public comment, but is implementing this guidance immediately in accordance with § 10.115(g)(2) and (3) without initially seeking prior comment because the agency has determined that prior public participation is not feasible or appropriate. In certain cases, donor retesting needs to be initiated quickly, and the availability of certain HCT/Ps may be critical to their intended recipients. Interested persons may, at VerDate Aug<31>2005 17:44 Jan 23, 2007 Jkt 211001 any time, submit to the Division of Dockets Management (See ADDRESSES) written or electronic comments regarding the 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 https:// www.fda.gov/cber/guidelines.htm or https://www.fda.gov/ohrms/dockets/ default.htm. Dated: January 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–978 Filed 1–23–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Agency Information Collection Activities: Visa Waiver Program Carrier Agreement (Form I–775) Bureau of Customs and Border Protection, Department of Homeland Security. ACTION: Proposed collection; comments requested. AGENCY: SUMMARY: The Bureau of Customs and Border Protection (CBP) of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995: Visa Waiver Program Carrier Agreement (Form I–775). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended without a change to the burden hours. This document is published to obtain comments form the public and affected agencies. This proposed information collection was previously published in the Federal Register (71 FR 67149) on November 20, 2006, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 This process is conducted in accordance with 5 CFR 1320.10. DATES: Written comments should be received on or before February 23, 2007. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to Nathan Lesser, Desk Officer, Department of Homeland Security/ Customs and Border Protection, and sent via electronic mail to oira_submission@omb.eop.gov or faxed to (202) 395–6974. SUPPLEMENTARY INFORMATION: The Bureau of Customs and Border Protection (CBP) encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act of 1995 (Pub. L.104–13). Your comments should address one of the following four points: (1) Evaluate whether the proposed collection of information is necessary for the Proper performance of the functions of the agency/component, including whether the information will have practical utility; (2) Evaluate the accuracy of the agencies/components estimate of the burden of The proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Title: Visa Waiver Program Carrier Agreement. OMB Number: 1651–0110. Form Number: Form I–775. Abstract: The Form I–775 provides for certain aliens to be exempt from the non-immigrant visa requirements if seeking entry as a visitor for no more than 90 days, provided that no potential threat exists to the security of the United States. Current Actions: There are no changes to the information collection. This submission is to extend the expiration date. Type of Review: Extension (without change). Affected Public: Individuals. Estimated Number of Respondents: 400. E:\FR\FM\24JAN1.SGM 24JAN1

Agencies

[Federal Register Volume 72, Number 15 (Wednesday, January 24, 2007)]
[Notices]
[Pages 3149-3150]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-978]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0017]


Guidance for Industry: Certain Human Cells, Tissues, and Cellular 
and Tissue-Based Products Recovered From Donors Who Were Tested for 
Communicable Diseases Using Pooled Specimens or Diagnostic Tests; 
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: Certain 
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 
Recovered From Donors Who Were Tested for Communicable Diseases Using 
Pooled Specimens or Diagnostic Tests'' dated January 2007. The guidance 
document provides establishments that make HCT/P donor eligibility 
determinations with recommendations concerning the donor eligibility 
requirements contained in 21 CFR part 1271, subpart C, which became 
effective on May 25, 2005. The guidance applies only to certain HCT/Ps 
that were not regulated as HCT/Ps before May 25, 2005, and that were 
recovered from donors beginning on or after the May 25, 2005, and 
within 30 days of the date of publication of this document in the 
Federal Register. This guidance has an immediate implementation date 
because FDA has determined that prior public participation is not 
feasible or appropriate. In certain cases, donor retesting needs to be 
initiated quickly, and the availability of certain HCT/Ps may be 
critical to their intended recipients.

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 (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 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 https://
www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, 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: Certain Human Cells, Tissues, and Cellular and 
Tissue-Based Products (HCT/Ps) Recovered From Donors Who

[[Page 3150]]

Were Tested for Communicable Diseases Using Pooled Specimens or 
Diagnostic Tests'' dated January 2007. The guidance document provides 
establishments that make HCT/P donor eligibility determinations with 
recommendations concerning the donor eligibility requirements under 
part 1271 (21 CFR part 1271), subpart C, when donors of certain HCT/Ps 
were tested for communicable diseases using pooled specimens or 
diagnostic tests. The effective date of the regulations contained in 
part 1271, subpart C, was May 25, 2005 (69 FR 29785, May 25, 2004). The 
guidance is applicable to certain HCT/Ps that were not regulated as 
HCT/Ps before May 25, 2005, and that were recovered from donors on or 
after May 25, 2005, and within 30 days of the date of publication of 
this document in the Federal Register. FDA has determined that donor 
retesting, in certain cases, needs to be conducted in a timely manner 
in order to be feasible, and the availability of certain HCT/Ps may be 
critical to their intended recipients.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation Sec.  10.115 (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 refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 
collections of information in part 1271, subpart C, have been approved 
under OMB control number 0910-0543; the collections of information in 
part 1271, subpart D, and Form FDA-3486 have been approved under OMB 
control number 0910-0559.

III. Comments

    FDA is soliciting public comment, but is implementing this guidance 
immediately in accordance with Sec.  10.115(g)(2) and (3) without 
initially seeking prior comment because the agency has determined that 
prior public participation is not feasible or appropriate. In certain 
cases, donor retesting needs to be initiated quickly, and the 
availability of certain HCT/Ps may be critical to their intended 
recipients. Interested persons may, at any time, submit to the Division 
of Dockets Management (See ADDRESSES) written or electronic comments 
regarding the 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 https://www.fda.gov/cber/guidelines.htm or https://www.fda.gov/
ohrms/dockets/default.htm.

    Dated: January 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-978 Filed 1-23-07; 8:45 am]
BILLING CODE 4160-01-S

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