Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 48825-48826 [2018-21042]

Download as PDF Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices electronic and written/paper comments 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance documents is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidances. Submit written requests for a single hard copy of the draft guidance documents entitled ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies Draft Companion Guidance Document’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Michael John, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993–0002, 301–796–6329, Michael.John@fda.hhs.gov or Kimberly Peters, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4314, Silver Spring, MD 20993–0002, 301–796–6350, Kimberly.Peters@fda.hhs.gov. SUPPLEMENTARY INFORMATION: daltland on DSKBBV9HB2PROD with NOTICES I. Background In the Federal Register of March 27, 2008, FDA published a notice of availability with a 120-day comment period to request comments on the draft guidances entitled ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and Clinical Studies Draft Companion Guidance Document.’’ The draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidances, when finalized, will represent the current thinking of FDA on coronary drug-eluting stents— nonclinical and clinical studies. They do not establish any rights for any person and are not binding on FDA or VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. The guidances are not subject to Executive Order 12866. FDA is reopening the comment period to consider any new information and intends to issue revised versions of these draft guidances for further consideration. This action will help the Center for Devices and Radiological Health fulfill its commitment to finalize, withdraw, or reopen the comment period for 50 percent of existing draft guidances issued prior to October 1, 2012 (82 FR 58429, December 12, 2017). FDA is reopening the comment period for 90 days. The Agency believes that a 90-day extension allows adequate time for interested parties to submit comments. Previously submitted comments do not need to be resubmitted for consideration. II. Electronic Access Persons interested in obtaining a copy of the draft guidances may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. The draft guidance documents are also available at https:// www.regulations.gov. Persons unable to download an electronic copy of ‘‘Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies’’ and ‘‘Coronary Drug-Eluting Stents— Nonclinical and Clinical Studies Draft Companion Guidance Document’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 6255 to identify the guidance you are requesting. Dated: September 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–21041 Filed 9–26–18; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 48825 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1752] Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.’’ The draft guidance, when finalized, establishes guidance for industry and FDA staff on how and when FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods. While FDA intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the draft guidance. FDA’s goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible. DATES: Submit either electronic or written comments on the draft guidance by November 26, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, E:\FR\FM\27SEN1.SGM 27SEN1 48826 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices daltland on DSKBBV9HB2PROD with NOTICES such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2018–D–1752 for ‘‘Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and FDA Staff.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Building, Rockville, MD 20857. Send one selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory Affairs, Division of Operational Policy, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240–402–8186, Christopher.henderson@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Frm 00034 Fmt 4703 II. Paperwork Reduction Act of 1995 This draft 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). Any collections of information under 21 CFR 7.46, 7.49, 7.53, 7.55, and 7.59 have been approved under OMB control number 0910–0249. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Safety/Recalls/ default.htm or https:// www.regulations.gov. Dated: September 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–21042 Filed 9–26–18; 8:45 am] FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.’’ The draft guidance, when finalized, establishes guidance for industry and FDA staff on how and when FDA intends to publicize retail consignees that may have received recalled foods. FDA’s goal is to publicize retail consignee lists for these food recalls, especially those that are likely to be classified as Class I recalls, where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as PO 00000 effectively and quickly as possible. FDA seeks comment on this draft guidance, including scope of the term ‘‘retail consignee’’ as used in this document, the situations where providing retail consignee lists would be of the most use to consumers to identify recalled food in their possession, and additional information that would be of the most use to consumers to help them identify recalled food in their possession. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA regarding publicizing retail consignees to effectuate certain food recalls. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866. Sfmt 4703 BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0007] Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2019 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare SUMMARY: E:\FR\FM\27SEN1.SGM 27SEN1

Agencies

[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48825-48826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21042]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1752]


Public Availability of Lists of Retail Consignees To Effectuate 
Certain Human and Animal Food Recalls; Draft Guidance for Industry and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of a draft guidance for industry and FDA 
staff entitled ``Public Availability of Lists of Retail Consignees to 
Effectuate Certain Human and Animal Food Recalls.'' The draft guidance, 
when finalized, establishes guidance for industry and FDA staff on how 
and when FDA intends to collect, compile, and publicize retail 
consignees that may have received recalled foods. While FDA intends to 
focus on recalls where there is a reasonable probability that the use 
of, or exposure to, the food will cause serious adverse health 
consequences or death to humans or animals (Class I recalls), FDA may 
also publicize retail consignee lists for other food recalls as 
described in the draft guidance. FDA's goal is to publicize retail 
consignee lists for these food recalls where providing this additional 
information will be of the most use to consumers to help them identify 
recalled food and to determine whether that food is in their possession 
as effectively and quickly as possible.

DATES: Submit either electronic or written comments on the draft 
guidance by November 26, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted,

[[Page 48826]]

such as medical information, your or anyone else's Social Security 
number, or confidential business information, such as a manufacturing 
process. Please note that if you include your name, contact 
information, or other information that identifies you in the body of 
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-1752 for ``Public Availability of Lists of Retail Consignees 
to Effectuate Certain Human and Animal Food Recalls; Draft Guidance for 
Industry and FDA Staff.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Strategic Planning and Operational Policy, Office of 
Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., 
Element Building, Rockville, MD 20857. Send one self-addressed adhesive 
label to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Henderson, Office of Regulatory 
Affairs, Division of Operational Policy, Food and Drug Administration, 
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8186, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Public Availability of Lists of Retail 
Consignees to Effectuate Certain Human and Animal Food Recalls.'' The 
draft guidance, when finalized, establishes guidance for industry and 
FDA staff on how and when FDA intends to publicize retail consignees 
that may have received recalled foods. FDA's goal is to publicize 
retail consignee lists for these food recalls, especially those that 
are likely to be classified as Class I recalls, where providing this 
additional information will be of the most use to consumers to help 
them identify recalled food and to determine whether that food is in 
their possession as effectively and quickly as possible. FDA seeks 
comment on this draft guidance, including scope of the term ``retail 
consignee'' as used in this document, the situations where providing 
retail consignee lists would be of the most use to consumers to 
identify recalled food in their possession, and additional information 
that would be of the most use to consumers to help them identify 
recalled food in their possession.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA regarding 
publicizing retail consignees to effectuate certain food recalls. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This draft 
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft 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). Any 
collections of information under 21 CFR 7.46, 7.49, 7.53, 7.55, and 
7.59 have been approved under OMB control number 0910-0249.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Safety/Recalls/default.htm or https://www.regulations.gov.

    Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21042 Filed 9-26-18; 8:45 am]
 BILLING CODE 4164-01-P

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