83 FR 48825 - Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 188 (September 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 188 (September 27, 2018)
| Page Range | 48825-48826 | |
| FR Document | 2018-21042 |
[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)] [Notices] [Pages 48825-48826] From the Federal Register Online [www.thefederalregister.org] [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FDA-2018-D-1752] Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal Food Recalls; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.'' The draft guidance, when finalized, establishes guidance for industry and FDA staff on how and when FDA intends to collect, compile, and publicize retail consignees that may have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or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the draft guidance.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 DATES: Submit either electronic or written comments on the draft guidance by November 26, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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
![Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices 48825
electronic and written/paper comments the public. You can use an alternative DEPARTMENT OF HEALTH AND
received, go to https:// approach if it satisfies the requirements HUMAN SERVICES
www.regulations.gov and insert the of the applicable statutes and
docket number, found in brackets in the regulations. The guidances are not Food and Drug Administration
heading of this document, into the subject to Executive Order 12866. [Docket No. FDA–2018–D–1752]
‘‘Search’’ box and follow the prompts
FDA is reopening the comment period
and/or go to the Dockets Management Public Availability of Lists of Retail
to consider any new information and
Staff, 5630 Fishers Lane, Rm. 1061, Consignees To Effectuate Certain
Rockville, MD 20852. intends to issue revised versions of
Human and Animal Food Recalls; Draft
You may submit comments on any these draft guidances for further
Guidance for Industry and Food and
guidance at any time (see 21 CFR consideration. This action will help the Drug Administration Staff; Availability
10.115(g)(5)). Center for Devices and Radiological
An electronic copy of the guidance Health fulfill its commitment to finalize, AGENCY: Food and Drug Administration,
documents is available for download withdraw, or reopen the comment HHS.
from the internet. See the period for 50 percent of existing draft ACTION: Notice of availability.
SUPPLEMENTARY INFORMATION section for guidances issued prior to October 1,
SUMMARY: The Food and Drug
information on electronic access to the 2012 (82 FR 58429, December 12, 2017). Administration (FDA, we, or Agency) is
guidances. Submit written requests for a FDA is reopening the comment period announcing the availability of a draft
single hard copy of the draft guidance for 90 days. The Agency believes that a guidance for industry and FDA staff
documents entitled ‘‘Coronary Drug- 90-day extension allows adequate time entitled ‘‘Public Availability of Lists of
Eluting Stents—Nonclinical and for interested parties to submit Retail Consignees to Effectuate Certain
Clinical Studies’’ and ‘‘Coronary Drug- comments. Previously submitted Human and Animal Food Recalls.’’ The
Eluting Stents—Nonclinical and comments do not need to be draft guidance, when finalized,
Clinical Studies Draft Companion establishes guidance for industry and
resubmitted for consideration.
Guidance Document’’ to the Office of FDA staff on how and when FDA
the Center Director, Guidance and II. Electronic Access intends to collect, compile, and
Policy Development, Center for Devices publicize retail consignees that may
and Radiological Health, Food and Drug Persons interested in obtaining a copy
have received recalled foods. While
Administration, 10903 New Hampshire of the draft guidances may do so by
FDA intends to focus on recalls where
Ave., Bldg. 66, Rm. 5431, Silver Spring, downloading an electronic copy from there is a reasonable probability that the
MD 20993–0002. Send one self- the internet. A search capability for all use of, or exposure to, the food will
addressed adhesive label to assist that Center for Devices and Radiological cause serious adverse health
office in processing your request. Health guidance documents is available consequences or death to humans or
FOR FURTHER INFORMATION CONTACT: at https://www.fda.gov/MedicalDevices/ animals (Class I recalls), FDA may also
Michael John, Center for Devices and DeviceRegulationandGuidance/ publicize retail consignee lists for other
Radiological Health, Food and Drug GuidanceDocuments/default.htm. The food recalls as described in the draft
Administration, 10903 New Hampshire draft guidance documents are also guidance. FDA’s goal is to publicize
Ave., Bldg. 66, Rm. 1224, Silver Spring, available at https:// retail consignee lists for these food
MD 20993–0002, 301–796–6329, www.regulations.gov. Persons unable to recalls where providing this additional
Michael.John@fda.hhs.gov or Kimberly download an electronic copy of information will be of the most use to
Peters, Center for Drug Evaluation and ‘‘Coronary Drug-Eluting Stents— consumers to help them identify
Research, Food and Drug Nonclinical and Clinical Studies’’ and recalled food and to determine whether
Administration, 10903 New Hampshire ‘‘Coronary Drug-Eluting Stents— that food is in their possession as
Ave., Bldg. 51, Rm. 4314, Silver Spring, Nonclinical and Clinical Studies Draft effectively and quickly as possible.
MD 20993–0002, 301–796–6350, Companion Guidance Document’’ may DATES: Submit either electronic or
Kimberly.Peters@fda.hhs.gov. send an email request to CDRH- written comments on the draft guidance
SUPPLEMENTARY INFORMATION: Guidance@fda.hhs.gov to receive an by November 26, 2018 to ensure that the
electronic copy of the document. Please Agency considers your comment on this
I. Background
use the document number 6255 to draft guidance before it begins work on
In the Federal Register of March 27, identify the guidance you are the final version of the guidance.
2008, FDA published a notice of ADDRESSES: You may submit comments
requesting.
availability with a 120-day comment as follows:
period to request comments on the draft Dated: September 21, 2018.
guidances entitled ‘‘Coronary Drug- Leslie Kux, Electronic Submissions
Eluting Stents—Nonclinical and Associate Commissioner for Policy. Submit electronic comments in the
Clinical Studies’’ and ‘‘Coronary Drug- [FR Doc. 2018–21041 Filed 9–26–18; 8:45 am] following way:
Eluting Stents—Nonclinical and • Federal eRulemaking Portal:
BILLING CODE 4164–01–P
Clinical Studies Draft Companion https://www.regulations.gov. Follow the
Guidance Document.’’ instructions for submitting comments.
The draft guidances are being issued Comments submitted electronically,
consistent with FDA’s good guidance including attachments, to https://
daltland on DSKBBV9HB2PROD with NOTICES
practices regulation (21 CFR 10.115). www.regulations.gov will be posted to
The draft guidances, when finalized, the docket unchanged. Because your
will represent the current thinking of comment will be made public, you are
FDA on coronary drug-eluting stents— solely responsible for ensuring that your
nonclinical and clinical studies. They comment does not include any
do not establish any rights for any confidential information that you or a
person and are not binding on FDA or third party may not wish to be posted,
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![48826 Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
such as medical information, your or information on the cover sheet and not effectively and quickly as possible. FDA
anyone else’s Social Security number, or in the body of your comments and you seeks comment on this draft guidance,
confidential business information, such must identify this information as including scope of the term ‘‘retail
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked consignee’’ as used in this document,
that if you include your name, contact as ‘‘confidential’’ will not be disclosed the situations where providing retail
information, or other information that except in accordance with 21 CFR 10.20 consignee lists would be of the most use
identifies you in the body of your and other applicable disclosure law. For to consumers to identify recalled food in
comments, that information will be more information about FDA’s posting their possession, and additional
posted on https://www.regulations.gov. of comments to public dockets, see 80 information that would be of the most
• If you want to submit a comment FR 56469, September 18, 2015, or access use to consumers to help them identify
with confidential information that you the information at: https://www.gpo.gov/ recalled food in their possession.
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- This draft guidance is being issued
public, submit the comment as a 23389.pdf. consistent with FDA’s good guidance
written/paper submission and in the Docket: For access to the docket to practices regulation (21 CFR 10.115).
manner detailed (see ‘‘Written/Paper read background documents or the The draft guidance, when finalized, will
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments represent the current thinking of FDA
Written/Paper Submissions received, go to https:// regarding publicizing retail consignees
www.regulations.gov and insert the to effectuate certain food recalls. It does
Submit written/paper submissions as docket number, found in brackets in the not establish any rights for any person
follows: heading of this document, into the and is not binding on FDA or the public.
• Mail/Hand Delivery/Courier (for You can use an alternative approach if
‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets it satisfies the requirements of the
and/or go to the Dockets Management
Management Staff (HFA–305), Food and applicable statutes and regulations. This
Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers draft guidance is not subject to
Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852. Executive Order 12866.
• For written/paper comments You may submit comments on any
submitted to the Dockets Management guidance at any time (see 21 CFR II. Paperwork Reduction Act of 1995
Staff, FDA will post your comment, as 10.115(g)(5)).
Submit written requests for single This draft guidance refers to
well as any attachments, except for previously approved collections of
information submitted, marked and copies of the draft guidance to the Office
of Strategic Planning and Operational information found in FDA regulations.
identified, as confidential, if submitted These collections of information are
as detailed in ‘‘Instructions.’’ Policy, Office of Regulatory Affairs,
Food and Drug Administration, 12420 subject to review by the Office of
Instructions: All submissions received Management and Budget (OMB) under
must include the Docket No. FDA– Parklawn Dr., Element Building,
Rockville, MD 20857. Send one self- the Paperwork Reduction Act of 1995
2018–D–1752 for ‘‘Public Availability of (44 U.S.C. 3501–3520). Any collections
Lists of Retail Consignees to Effectuate addressed adhesive label to assist that
office in processing your requests. See of information under 21 CFR 7.46, 7.49,
Certain Human and Animal Food 7.53, 7.55, and 7.59 have been approved
Recalls; Draft Guidance for Industry and the SUPPLEMENTARY INFORMATION section
for electronic access to the draft under OMB control number 0910–0249.
FDA Staff.’’ Received comments will be
placed in the docket and, except for guidance document. III. Electronic Access
those submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
Persons with access to the internet
Submissions,’’ publicly viewable at Chris Henderson, Office of Regulatory may obtain the draft guidance at either
https://www.regulations.gov or at the Affairs, Division of Operational Policy, https://www.fda.gov/Safety/Recalls/
Dockets Management Staff between 9 Food and Drug Administration, 12420 default.htm or https://
a.m. and 4 p.m., Monday through Parklawn Dr., Rockville, MD 20857, www.regulations.gov.
Friday. 240–402–8186, Christopher.henderson@
Dated: September 21, 2018.
• Confidential Submissions—To fda.hhs.gov.
submit a comment with confidential Leslie Kux,
SUPPLEMENTARY INFORMATION:
information that you do not wish to be Associate Commissioner for Policy.
made publicly available, submit your I. Background [FR Doc. 2018–21042 Filed 9–26–18; 8:45 am]
comments only as a written/paper FDA is announcing the availability of BILLING CODE 4164–01–P
submission. You should submit two a draft guidance for industry and FDA
copies total. One copy will include the staff entitled ‘‘Public Availability of
information you claim to be confidential Lists of Retail Consignees to Effectuate DEPARTMENT OF HEALTH AND
with a heading or cover note that states Certain Human and Animal Food HUMAN SERVICES
‘‘THIS DOCUMENT CONTAINS Recalls.’’ The draft guidance, when
Food and Drug Administration
CONFIDENTIAL INFORMATION.’’ The finalized, establishes guidance for
Agency will review this copy, including industry and FDA staff on how and [Docket No. FDA–2018–N–0007]
the claimed confidential information, in when FDA intends to publicize retail
its consideration of comments. The consignees that may have received Fee for Using a Rare Pediatric Disease
second copy, which will have the recalled foods. FDA’s goal is to Priority Review Voucher in Fiscal Year
claimed confidential information publicize retail consignee lists for these 2019
daltland on DSKBBV9HB2PROD with NOTICES
redacted/blacked out, will be available food recalls, especially those that are AGENCY: Food and Drug Administration,
for public viewing and posted on likely to be classified as Class I recalls, HHS.
https://www.regulations.gov. Submit where providing this additional ACTION: Notice.
both copies to the Dockets Management information will be of the most use to
Staff. If you do not wish your name and consumers to help them identify SUMMARY: The Food and Drug
contact information to be made publicly recalled food and to determine whether Administration (FDA or the Agency) is
available, you can provide this that food is in their possession as announcing the fee rate for using a rare
VerDate Sep<11>2014 17:20 Sep 26, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\27SEN1.SGM 27SEN1](https://thefederalregister.org/doc/83_FR_49013/page/2.svg)
Document Created: 2018-09-27 01:03:59
Document Modified: 2018-09-27 01:03:59
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 48825 |
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