Designation of High-Risk Foods for Tracing and for Scientific Data and Information; Extension of Comment Period, 16800-16801 [2014-06615]

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 Federal Register / Vol. 79, No. 58 / Wednesday, March 26, 2014 / Notices Dated: March 20, 2014. Leslie Kux, Assistant Commissioner for Policy. SUPPLEMENTARY INFORMATION: [FR Doc. 2014–06615 Filed 3–25–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0477] Center for Devices and Radiological Health: Standard Operating Procedure for Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the Standard Operating Procedure (SOP) for Level 1, Immediately in Effect (IIE) Guidance Documents on Premarket Data Issues. The SOP describes the Center for Devices and Radiological Health’s (CDRH’s or the Center’s) process to clarify and more quickly inform stakeholders when CDRH has changed its expectations relating to, or otherwise has new scientific information that could affect data submitted as part of an Investigational Device Exemption (IDE) or premarket submission, including a Premarket Notification (510(k)), a Premarket Approval (PMA), a Humanitarian Device Exemption (HDE), or combination products containing a device constituent part for which CDRH has jurisdiction that needs to be disseminated in a timely manner. DATES: Submit either electronic or written comments on this SOP at any time. General comments on Agency SOP documents are welcome at any time. ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on electronic access to the SOP. Submit electronic comments on the SOP to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993–0002, 301–796–5678, Philip.desjardins@fda.hhs.gov. sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:43 Mar 25, 2014 Jkt 232001 I. Background The Task Force on the Utilization of Science in Regulatory Decision Making (the Task Force) published a Preliminary Report and Recommendations in August 2010. In the report, the Task Force noted that when new scientific information changes CDRH’s regulatory thinking, it has been challenging for the Center to communicate the change and its basis to all affected parties in a meaningful and timely manner. The Task Force recommended that the Center make use of more rapid tools for broad communication on regulatory matters, including establishing a standard practice for communicating to all manufacturers of a particular group of devices for which the Center has changed its regulatory expectations on the basis of new scientific information. Currently, manufacturers typically learn of changes CDRH implements regarding what data or how to gather specific data in support of an IDE or premarket submission at the time of or soon after a decision is made through individual engagement with the Center, often not until after they have prepared that submission. Reviewers may implement these changes, such as requesting new clinical data or using a new test method, on a case-by-case basis, with immediate supervisory concurrence when it is necessary to protect the public health. For example, a reviewer may request that sponsors test their implantable device for durability because new data demonstrate that this type of device is prone to failure due to premature wear and tear of the technology. Although CDRH may issue a detailed guidance document, the document may not be published until a year or more after a Branch- or Division-level decision has been made to request the information because of the resource constraints in developing guidance documents. CDRH believes that timely communication with industry about changes in premarket regulatory expectations is important. FDA’s Good Guidance Practices regulation provides a mechanism for communicating and implementing certain changes in regulatory expectations quickly, without requiring prior public comment. Under 21 CFR 10.115(g)(2), FDA may issue a Level 1, IIE Guidance Document when prior public participation is not ‘‘feasible or appropriate.’’ Under these circumstances, CDRH intends to use the procedures described in § 10.115(g)(2) to issue guidance documents addressing changes in premarket regulatory PO 00000 Frm 00048 Fmt 4703 Sfmt 9990 16801 expectations. CDRH has developed this SOP to facilitate issuance of such guidance documents. On September 5, 2013 (78 FR 54655), CDRH issued a draft SOP that meets the Center’s needs and addresses concerns raised regarding an original ‘‘Notice to Industry Letters’’ proposal (July 21, 2011, 76 FR 43693). Interested persons were invited to comment by October 21, 2013. Three comments were received with suggestions pertaining to the administrative process and policies regarding IIE guidances. In response to these comments, FDA revised the SOP to clarify the processes and policies as appropriate. This document will supersede the ‘‘Draft Standard Operating Procedure for Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues’’ issued on September 5, 2013. II. Electronic Access Persons interested in obtaining a copy of the SOP may do so by using the Internet. The Standard Operating Procedure for Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues is available at https://www.fda.gov/downloads/ MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/UCM259172.pdf. The SOP is also available from https:// www.regulations.gov and can be located using the docket number found in brackets in the heading of this document. III. 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. Dated: March 20, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–06611 Filed 3–25–14; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\26MRN1.SGM 26MRN1

Agencies

[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Notices]
[Pages 16800-16801]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06615]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0053]


Designation of High-Risk Foods for Tracing and for Scientific 
Data and Information; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for the notice entitled ``Designation of High-Risk 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.

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 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 high-risk 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 45-day 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.


[[Page 16801]]


    Dated: March 20, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06615 Filed 3-25-14; 8:45 am]
BILLING CODE 4160-01-P
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