Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 16800 [2014-06616]

Download as PDF 16800 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2014–N–0053] [Docket No. FDA–2013–N–0731] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Designation of High-Risk Foods for Tracing and for Scientific Data and Information; Extension of Comment Period AGENCY: ACTION: AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On January 28, 2014, the Agency submitted a proposed collection of information entitled ‘‘Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0543. The approval expires on March 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: March 20, 2014. Leslie Kux, Assistant Commissioner for Policy. sroberts on DSK5SPTVN1PROD with NOTICES [FR Doc. 2014–06616 Filed 3–25–14; 8:45 am] BILLING CODE 4160–01–P 17:43 Mar 25, 2014 Notice; extension of comment period. The Food and Drug Administration (FDA or we) is extending the comment period for the notice entitled ‘‘Designation of HighRisk Foods for Tracing; Request for Comments and for Scientific Data and Information’’ that appeared in the Federal Register of February 4, 2014 (79 FR 6596). In the notice, FDA requested comments and scientific data and information that will help us to implement the section of the FDA Food Safety Modernization Act (FSMA) that requires us to designate high-risk foods. FDA is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit either electronic or written comments on the notice by May 22, 2014. ADDRESSES: You may submit comments and information, identified by Docket No. FDA–2014–N–0053, by any of the following methods. SUMMARY: Notice. VerDate Mar<15>2010 Food and Drug Administration, HHS. Jkt 232001 Electronic Submissions Submit electronic comments and information in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments and information. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2014–N–0053 for this notice. All comments and information received may be posted without change to https://www.regulations.gov, including any personal information provided. For additional information on submitting comments and information, see the ‘‘Request for Comments’’ heading of the PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or comments and information received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sherri Dennis, Center for Food Safety and Applied Nutrition (HFS–005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1914. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of February 4, 2014 (79 FR 6596), FDA published a notice with a 60-day comment period to request comments and scientific data and information that will help us refine our draft approach to identifying highrisk foods, as required by section 204(d)(2) of FSMA (Pub. L. 111–353). The notice summarized our draft approach for the review and evaluation of data to designate high-risk foods. We invited general comments on the draft approach, along with requests for more specific input on alternative approaches for identifying high-risk foods, whether or not the criteria should be weighted equally, changes in the scoring system, and how foods should be categorized. FDA has received requests for extension of the comment period for the notice. Each request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the notice. FDA has considered the requests and is extending the comment period for all interested persons for 45 days, until May 22, 2014. FDA believes that a 45day extension allows adequate time for interested persons to submit comments. II. Request for Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments 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, and will be posted to the docket at https:// www.regulations.gov. E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Page 16800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06616]



[[Page 16800]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0731]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Eligibility Determination for Donors 
of Human Cells, Tissues, and Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Eligibility Determination for 
Donors of Human Cells, Tissues, and Cellular and Tissue-Based 
Products'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On January 28, 2014, the Agency submitted a 
proposed collection of information entitled ``Eligibility Determination 
for Donors of Human Cells, Tissues, and Cellular and Tissue-Based 
Products'' to OMB for review and clearance under 44 U.S.C. 3507. An 
Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. OMB has now approved the information 
collection and has assigned OMB control number 0910-0543. The approval 
expires on March 31, 2017. A copy of the supporting statement for this 
information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: March 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06616 Filed 3-25-14; 8:45 am]
BILLING CODE 4160-01-P
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