81 FR 25408 - Compliance Policy Guide on Crabmeat-Fresh and Frozen-Adulteration With Filth, Involving the Presence of Escherichia coli
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 82 (April 28, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 82 (April 28, 2016)
| Page Range | 25408-25409 | |
| FR Document | 2016-09951 |
[Federal Register Volume 81, Number 82 (Thursday, April 28, 2016)] [Notices] [Pages 25408-25409] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09951] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1842] Compliance Policy Guide on Crabmeat--Fresh and Frozen-- Adulteration With Filth, Involving the Presence of Escherichia coli AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a Compliance Policy Guide (CPG) relating to fresh and frozen crabmeat adulteration with filth involving the presence of Escherichia coli (E. coli). The CPG updates the previously issued CPG on this topic. The CPG provides guidance for FDA staff on the level of E. coli in crabmeat at which we may consider the crabmeat to be adulterated with filth. DATES: Submit electronic or written comments on FDA's CPGs at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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, 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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2014-D-1842 for ``Compliance Policy Guide on Crabmeat--Fresh and Frozen--Adulteration with Filth, Involving the Presence of Escherichia coli.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to Office of Policy and Risk Management, Office of Regulatory Affairs, Office of Global Regulatory Operations and Policy, Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Mary E. Losikoff, Center for Food Safety and Applied Nutrition (HFC-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2300. SUPPLEMENTARY INFORMATION: [[Page 25409]] I. Background We are announcing the availability of revised CPG Sec. 540.275 Crabmeat--Fresh and Frozen--Adulteration with Filth, Involving the Presence of Escherichia coli. The CPG updates the previously issued CPG Sec. 540.275 Crabmeat--Fresh and Frozen--Adulteration with Filth, Involving the Presence of Escherichia coli. We are issuing this CPG consistent with our good guidance practices regulation (21 CFR 10.115). The CPG represents the current thinking of FDA on this topic. 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. The CPG provides guidance for FDA staff on the level of E. coli in fresh or frozen crabmeat (i.e., 3.6 Most Probable Number per gram (MPN/ g) of E. coli) at which FDA may consider the crabmeat to be adulterated with filth under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(4)). We revised the CPG for clarity and to update the format. Revisions generally include the addition of sections on Background and Policy, updates to the sections on Regulatory Action Guidance and Specimen Charges, and FDA office names. The CPG provides criteria that the FDA District Offices may use to determine whether to recommend an enforcement action. Consistent with our standard business process, the CPG provides guidance to the FDA field offices for submitting an enforcement action recommendation to FDA's Center for Food Safety and Applied Nutrition (CFSAN) for case review. The CPG also provides direct reference authority to the FDA field offices in certain situations. Rather than submitting the recommendation to CFSAN, direct reference authority allows the FDA field offices to submit the recommendation directly to the appropriate office in FDA's Office of Regulatory Affairs, thus streamlining the Agency's internal case review process. Specifically, in the section on Regulatory Action Guidance, we clarify that FDA's District Offices have direct reference authority for both domestic seizure and import refusal based on the criteria described in the CPG. We also clarify the specific types of legal action to which the criteria for recommendations apply. In addition, we provide specimen charges relating to domestic seizure and import refusal. The CPG also contains information that may be useful to the regulated industry and to the public. In the Federal Register of December 16, 2014 (79 FR 74729), we made available draft CPG Sec. 540.275 ``Crabmeat--Fresh and Frozen-- Adulteration with Filth, Involving the Presence of Escherichia coli.'' We gave interested parties an opportunity to submit comments on the draft CPG by February 17, 2015, for us to consider before beginning work on the final version of the CPG. We received no comments on the draft CPG. We are issuing the CPG with no changes other than for clarity and to update the format. The CPG announced in this notice finalizes the draft CPG dated December 2014. II. Electronic Access Persons with access to the Internet may obtain the CPG at either http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the CPG. Dated: April 25, 2016. Katherine Bent, Assistant Commissioner for Compliance Policy. [FR Doc. 2016-09951 Filed 4-27-16; 8:45 am] BILLING CODE 4164-01-P
![25408 Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Notices
and Services Program, 330 C Street SW., DATES: Submit electronic or written information that you do not wish to be
3rd Floor, Suite 3621B, Washington, DC comments on FDA’s CPGs at any time. made publicly available, submit your
20201. Telephone: 202–401–5524; ADDRESSES: You may submit comments comments only as a written/paper
Email: Angela.Yannelli@acf.hhs.gov. as follows: submission. You should submit two
SUPPLEMENTARY INFORMATION: The copies total. One copy will include the
Electronic Submissions
Hotline in Austin, TX, is funded under information you claim to be confidential
the Family Violence Protection and Submit electronic comments in the with a heading or cover note that states
Services Act (FVPSA) program to following way: ‘‘THIS DOCUMENT CONTAINS
operate the 24-hour, national, toll-free • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
telephone hotline that provides www.regulations.gov. Follow the
Agency will review this copy, including
information and assistance to adult and instructions for submitting comments.
the claimed confidential information, in
youth victims of family violence, Comments submitted electronically,
its consideration of comments. The
domestic violence, or dating violence, including attachments, to http://
second copy, which will have the
and to the family and household www.regulations.gov will be posted to
the docket unchanged. Because your claimed confidential information
members of such victims, and to redacted/blacked out, will be available
persons affected by the victimization. comment will be made public, you are
solely responsible for ensuring that your for public viewing and posted on
The supplemental award will expand
comment does not include any http://www.regulations.gov. Submit
the capacity of the Hotline’s current
confidential information that you or a both copies to the Division of Dockets
efforts by focusing on the development
of a tribal hotline and by providing third party may not wish to be posted, Management. If you do not wish your
additional phone advocates to ensure such as medical information, your or name and contact information to be
that the Hotline can answer all contacts. anyone else’s Social Security number, or made publicly available, you can
The award will also assist in developing confidential business information, such provide this information on the cover
the ‘‘Love Is Respect’’ Web site (http:// as a manufacturing process. Please note sheet and not in the body of your
www.loveisrespect.org) into a complete that if you include your name, contact comments and you must identify this
resource for teens and youth seeking to information, or other information that information as ‘‘confidential.’’ Any
prevent and end abusive relationships. identifies you in the body of your information marked as ‘‘confidential’’
Statutory Authority: The statutory comments, that information will be will not be disclosed except in
authority for the award is section 313 of the posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Family Violence Prevention and Services Act • If you want to submit a comment applicable disclosure law. For more
(42 U.S.C. 10413) as amended by section 201 with confidential information that you information about FDA’s posting of
of the CAPTA Reauthorization Act of 2010 do not wish to be made available to the comments to public dockets, see 80 FR
(Pub. L. 111–320). public, submit the comment as a 56469, September 18, 2015, or access
Christopher Beach, written/paper submission and in the the information at: http://www.fda.gov/
Senior Grants Policy Specialist, Division of
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Grants Policy, Office of Administration, Submissions’’ and ‘‘Instructions’’). default.htm.
Administration for Children and Families. Written/Paper Submissions Docket: For access to the docket to
[FR Doc. 2016–09925 Filed 4–27–16; 8:45 am] read background documents or the
Submit written/paper submissions as
BILLING CODE 4184–32–P
follows: electronic and written/paper comments
• Mail/Hand delivery/Courier (for received, go to http://
written/paper submissions): Division of www.regulations.gov and insert the
DEPARTMENT OF HEALTH AND
Dockets Management (HFA–305), Food docket number, found in brackets in the
HUMAN SERVICES
and Drug Administration, 5630 Fishers heading of this document, into the
Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
• For written/paper comments and/or go to the Division of Dockets
[Docket No. FDA–2014–D–1842] submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm.
Management, FDA will post your 1061, Rockville, MD 20852.
Compliance Policy Guide on comment, as well as any attachments,
Crabmeat—Fresh and Frozen— Submit written requests for single
except for information submitted,
Adulteration With Filth, Involving the copies of the guidance to Office of
marked and identified, as confidential,
Presence of Escherichia coli Policy and Risk Management, Office of
if submitted as detailed in
Regulatory Affairs, Office of Global
AGENCY: Food and Drug Administration, ‘‘Instructions.’’
Instructions: All submissions received Regulatory Operations and Policy, Food
HHS.
must include the Docket No. FDA– and Drug Administration, 12420
ACTION: Notice of availability. Parklawn Dr., Rockville, MD 20857.
2014–D–1842 for ‘‘Compliance Policy
SUMMARY: The Food and Drug Guide on Crabmeat—Fresh and Send two self-addressed adhesive labels
Administration (FDA or we) is Frozen—Adulteration with Filth, to assist that office in processing your
announcing the availability of a Involving the Presence of Escherichia request. See the SUPPLEMENTARY
Compliance Policy Guide (CPG) relating coli.’’ Received comments will be INFORMATION section for electronic
to fresh and frozen crabmeat placed in the docket and, except for access to the guidance.
adulteration with filth involving the those submitted as ‘‘Confidential
mstockstill on DSK3G9T082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
presence of Escherichia coli (E. coli). Submissions,’’ publicly viewable at Mary E. Losikoff, Center for Food Safety
The CPG updates the previously issued http://www.regulations.gov or at the and Applied Nutrition (HFC–820), Food
CPG on this topic. The CPG provides Division of Dockets Management and Drug Administration, 5100 Paint
guidance for FDA staff on the level of E. between 9 a.m. and 4 p.m., Monday Branch Pkwy., College Park, MD 20740,
coli in crabmeat at which we may through Friday. 240–402–2300.
consider the crabmeat to be adulterated • Confidential Submissions—To
with filth. submit a comment with confidential SUPPLEMENTARY INFORMATION:
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![Federal Register / Vol. 81, No. 82 / Thursday, April 28, 2016 / Notices 25409
I. Background In the Federal Register of December DATES: Submit either electronic or
We are announcing the availability of 16, 2014 (79 FR 74729), we made written comments on the collection of
revised CPG Sec. 540.275 Crabmeat— available draft CPG Sec. 540.275 information by June 27, 2016.
Fresh and Frozen—Adulteration with ‘‘Crabmeat—Fresh and Frozen— ADDRESSES: You may submit comments
Filth, Involving the Presence of Adulteration with Filth, Involving the as follows:
Escherichia coli. The CPG updates the Presence of Escherichia coli.’’ We gave
interested parties an opportunity to Electronic Submissions
previously issued CPG Sec. 540.275
Crabmeat—Fresh and Frozen— submit comments on the draft CPG by Submit electronic comments in the
Adulteration with Filth, Involving the February 17, 2015, for us to consider following way:
before beginning work on the final • Federal eRulemaking Portal: http://
Presence of Escherichia coli. We are
version of the CPG. We received no www.regulations.gov. Follow the
issuing this CPG consistent with our
comments on the draft CPG. We are instructions for submitting comments.
good guidance practices regulation (21
issuing the CPG with no changes other Comments submitted electronically,
CFR 10.115). The CPG represents the
than for clarity and to update the including attachments, to http://
current thinking of FDA on this topic.
format. The CPG announced in this www.regulations.gov will be posted to
It does not establish any rights for any
notice finalizes the draft CPG dated the docket unchanged. Because your
person and is not binding on FDA or the
December 2014. comment will be made public, you are
public. You can use an alternative
solely responsible for ensuring that your
approach if it satisfies the requirements II. Electronic Access comment does not include any
of the applicable statutes and
Persons with access to the Internet confidential information that you or a
regulations.
The CPG provides guidance for FDA may obtain the CPG at either http:// third party may not wish to be posted,
staff on the level of E. coli in fresh or www.fda.gov/ICECI/Compliance such as medical information, your or
frozen crabmeat (i.e., 3.6 Most Probable Manuals/CompliancePolicyGuidance anyone else’s Social Security number, or
Number per gram (MPN/g) of E. coli) at Manual/default.htm or http:// confidential business information, such
which FDA may consider the crabmeat www.regulations.gov. Use the FDA Web as a manufacturing process. Please note
to be adulterated with filth under site listed in the previous sentence to that if you include your name, contact
section 402(a)(4) of the Federal Food, find the most current version of the information, or other information that
Drug, and Cosmetic Act (21 U.S.C. CPG. identifies you in the body of your
342(a)(4)). We revised the CPG for Dated: April 25, 2016.
comments, that information will be
clarity and to update the format. posted on http://www.regulations.gov.
Katherine Bent,
• If you want to submit a comment
Revisions generally include the addition Assistant Commissioner for Compliance with confidential information that you
of sections on Background and Policy, Policy.
do not wish to be made available to the
updates to the sections on Regulatory [FR Doc. 2016–09951 Filed 4–27–16; 8:45 am] public, submit the comment as a
Action Guidance and Specimen BILLING CODE 4164–01–P written/paper submission and in the
Charges, and FDA office names. The
manner detailed (see ‘‘Written/Paper
CPG provides criteria that the FDA
Submissions’’ and ‘‘Instructions’’).
District Offices may use to determine DEPARTMENT OF HEALTH AND
whether to recommend an enforcement HUMAN SERVICES Written/Paper Submissions
action. Consistent with our standard Submit written/paper submissions as
business process, the CPG provides Food and Drug Administration follows:
guidance to the FDA field offices for • Mail/Hand delivery/Courier (for
submitting an enforcement action [Docket No. FDA–2013–N–0557]
written/paper submissions): Division of
recommendation to FDA’s Center for Dockets Management (HFA–305), Food
Agency Information Collection
Food Safety and Applied Nutrition and Drug Administration, 5630 Fishers
Activities; Proposed Collection;
(CFSAN) for case review. The CPG also Lane, Rm. 1061, Rockville, MD 20852.
Comment Request; Postmarket
provides direct reference authority to
Surveillance • For written/paper comments
the FDA field offices in certain submitted to the Division of Dockets
situations. Rather than submitting the AGENCY: Food and Drug Administration, Management, FDA will post your
recommendation to CFSAN, direct HHS. comment, as well as any attachments,
reference authority allows the FDA field ACTION: Notice. except for information submitted,
offices to submit the recommendation marked and identified, as confidential,
directly to the appropriate office in SUMMARY: The Food and Drug if submitted as detailed in
FDA’s Office of Regulatory Affairs, thus Administration (FDA) is announcing an ‘‘Instructions.’’
streamlining the Agency’s internal case opportunity for public comment on the Instructions: All submissions received
review process. Specifically, in the proposed collection of certain must include the Docket No. FDA–
section on Regulatory Action Guidance, information by the Agency. Under the 2013–N–0557 for ‘‘Agency Information
we clarify that FDA’s District Offices Paperwork Reduction Act of 1995 (the Collection Activities; Proposed
have direct reference authority for both PRA), Federal Agencies are required to Collection; Comment Request;
domestic seizure and import refusal publish notice in the Federal Register Postmarket Surveillance.’’ Received
based on the criteria described in the concerning each proposed collection of comments will be placed in the docket
CPG. We also clarify the specific types information, including each proposed and, except for those submitted as
mstockstill on DSK3G9T082PROD with NOTICES
of legal action to which the criteria for extension of an existing collection of ‘‘Confidential Submissions,’’ publicly
recommendations apply. In addition, we information, and to allow 60 days for viewable at http://www.regulations.gov
provide specimen charges relating to public comment in response to the or at the Division of Dockets
domestic seizure and import refusal. notice. This notice solicits comments on Management between 9 a.m. and 4 p.m.,
The CPG also contains information that information collection requirements for Monday through Friday.
may be useful to the regulated industry postmarket surveillance of medical • Confidential Submissions—To
and to the public. devices. submit a comment with confidential
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Document Created: 2016-04-28 01:05:18
Document Modified: 2016-04-28 01:05:18
| 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 electronic or written comments on FDA's CPGs at any time. | |
| Contact | Mary E. Losikoff, Center for Food Safety and Applied Nutrition (HFC-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2300. | |
| FR Citation | 81 FR 25408 |
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