80 FR 26269 - Questions and Answers Regarding Mandatory Food Recalls; Draft Guidance for Industry

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26269-26269
FR Document		2015-11009

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry on the implementation of the mandatory food recall provisions of the FDA Food Safety Modernization Act (FSMA). The guidance is in the form of Questions and Answers and provides answers to common questions that might arise about the mandatory recall provisions and FDA's plans for their implementation.

Federal Register, Volume 80 Issue 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Page 26269]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-11009]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0138]

Questions and Answers Regarding Mandatory Food Recalls; Draft
Guidance for Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft guidance for industry on the implementation of
the mandatory food recall provisions of the FDA Food Safety
Modernization Act (FSMA). The guidance is in the form of Questions and
Answers and provides answers to common questions that might arise about
the mandatory recall provisions and FDA's plans for their
implementation.

DATES: Although you may comment on any guidance at any time, to ensure
that the Agency considers your comments on this draft guidance before
it completes a final version of the guidance, submit electronic or
written comments on the draft guidance by July 6, 2015.

ADDRESSES: Submit written requests for single copies of the guidance to
the Outreach and Information Center (HFS-009), Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740. 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.
Submit electronic comments on the guidance to http://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.

FOR FURTHER INFORMATION CONTACT: Cecilia M. Wolyniak, Food and Drug
Administration, WO32 Rm. 4352 HFC-210, 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002, 301-796-8209.

SUPPLEMENTARY INFORMATION:

I. Background

FDA's mandatory food recall authority went into effect when FSMA
was enacted on January 4, 2011. Section 423 of the Federal Food, Drug
and Cosmetic Act (FD&C Act), as added by section 206 of FSMA, gives FDA
the authority to order a responsible party to recall an article of food
where FDA determines that there is a reasonable probability that the
article of food (other than infant formula) is adulterated under
section 402 of the FD&C Act [21 U.S.C. 342] or misbranded under section
403(w) of the FD&C Act [21 U.S.C. 343(w)] and that the use of or
exposure to such article will cause serious adverse health consequences
or death to humans or animals (SAHCODHA).
FDA is announcing the availability of a draft guidance for industry
entitled ``Questions and Answers Regarding Mandatory Food Recalls;
Draft Guidance for Industry.'' The draft guidance provides answers to
common questions that might arise about the mandatory recall provisions
and FDA's plans for their implementation.
This guidance is being issued consistent with our good guidance
practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent our current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

This guidance does not refer to any information collection
provisions found in FDA regulations. 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). We conclude
that the Draft Guidance for Industry: Questions and Answers Regarding
Mandatory Food Recalls is not subject to Paperwork Reduction Act of
1995.

III. Comments

Interested persons may submit either written comments regarding the
guidance to the Division of Dockets Management (see ADDRESSES) or
electronic comments regarding the guidance to http://www.regulations.gov. 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 http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11009 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26269

Anyone with knowledge that any of and FDA’s plans for their topic. It does not create or confer any
the dates as published are incorrect may implementation. rights for or on any person and does not
submit to the Division of Dockets DATES: Although you may comment on operate to bind FDA or the public. An
Management (see ADDRESSES) either any guidance at any time, to ensure that alternative approach may be used if
electronic or written comments and ask the Agency considers your comments on such approach satisfies the
for a redetermination by July 6, 2015. this draft guidance before it completes requirements of the applicable statutes
Furthermore, any interested person may a final version of the guidance, submit and regulations.
petition FDA for a determination electronic or written comments on the II. Paperwork Reduction Act of 1995
regarding whether the applicant for draft guidance by July 6, 2015.
extension acted with due diligence This guidance does not refer to any
ADDRESSES: Submit written requests for information collection provisions found
during the regulatory review period by single copies of the guidance to the
November 3, 2015. To meet its burden, in FDA regulations. Collections of
Outreach and Information Center (HFS– information are subject to review by the
the petition must contain sufficient facts 009), Center for Food Safety and
to merit an FDA investigation. (See H. Office of Management and Budget
Applied Nutrition (HFS–317), Food and (OMB) under the Paperwork Reduction
Rept. 857, part 1, 98th Cong., 2d sess., Drug Administration, 5100 Paint Branch
pp. 41–42, 1984.) Petitions should be in Act of 1995 (44 U.S.C. 3501–3520). We
Pkwy., College Park, MD 20740. Send conclude that the Draft Guidance for
the format specified in 21 CFR 10.30. two self-addressed adhesive labels to
Interested persons may submit to the Industry: Questions and Answers
assist that office in processing your Regarding Mandatory Food Recalls is
Division of Dockets Management (see request. See the SUPPLEMENTARY
ADDRESSES) electronic or written not subject to Paperwork Reduction Act
INFORMATION section for electronic of 1995.
comments and written or electronic access to the guidance.
petitions. It is only necessary to send Submit electronic comments on the III. Comments
one set of comments. Identify comments guidance to http://www.regulations.gov. Interested persons may submit either
with the docket number found in Submit written comments to the written comments regarding the
brackets in the heading of this Division of Dockets Management (HFA– guidance to the Division of Dockets
document. If you submit a written 305), Food and Drug Administration, Management (see ADDRESSES) or
petition, two copies are required. A 5630 Fishers Lane, Rm. 1061, Rockville, electronic comments regarding the
petition submitted electronically must MD 20852. guidance to http://www.regulations.gov.
be submitted to http:// FOR FURTHER INFORMATION CONTACT: It is only necessary to send one set of
www.regulations.gov, Docket No. FDA– Cecilia M. Wolyniak, Food and Drug comments. Identify comments with the
2013–S–0610. Comments and petitions Administration, WO32 Rm. 4352 HFC– docket number found in brackets in the
that have not been made publicly 210, 10903 New Hampshire Ave., Silver heading of this document. Received
available on http://www.regulations.gov Spring, MD 20993–0002, 301–796–8209. comments may be seen in the Division
may be viewed in the Division of
SUPPLEMENTARY INFORMATION: of Dockets Management between 9 a.m.
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
and 4 p.m., Monday through Friday. I. Background will be posted to the docket at http://
Dated: May 1, 2015. FDA’s mandatory food recall www.regulations.gov.
Leslie Kux, authority went into effect when FSMA
was enacted on January 4, 2011. Section IV. Electronic Access
Associate Commissioner for Policy.
[FR Doc. 2015–10999 Filed 5–6–15; 8:45 am] 423 of the Federal Food, Drug and Persons with access to the Internet
Cosmetic Act (FD&C Act), as added by may obtain the guidance at either
BILLING CODE 4164–01–P
section 206 of FSMA, gives FDA the http://www.fda.gov/FoodGuidances or
authority to order a responsible party to http://www.regulations.gov. Use the
DEPARTMENT OF HEALTH AND recall an article of food where FDA FDA Web site listed in the previous
HUMAN SERVICES determines that there is a reasonable sentence to find the most current
probability that the article of food (other version of the guidance.
Food and Drug Administration than infant formula) is adulterated Dated: May 1, 2015.
under section 402 of the FD&C Act [21 Leslie Kux,
[Docket No. FDA–2015–D–0138]
U.S.C. 342] or misbranded under section Associate Commissioner for Policy.
Questions and Answers Regarding 403(w) of the FD&C Act [21 U.S.C. [FR Doc. 2015–11009 Filed 5–6–15; 8:45 am]
Mandatory Food Recalls; Draft 343(w)] and that the use of or exposure
BILLING CODE 4164–01–P
Guidance for Industry to such article will cause serious
adverse health consequences or death to
AGENCY: Food and Drug Administration, humans or animals (SAHCODHA). DEPARTMENT OF HEALTH AND
HHS. FDA is announcing the availability of HUMAN SERVICES
ACTION: Notice of availability. a draft guidance for industry entitled
‘‘Questions and Answers Regarding Food and Drug Administration
SUMMARY: The Food and Drug Mandatory Food Recalls; Draft Guidance
Administration (FDA or we) is for Industry.’’ The draft guidance [Docket No. FDA–2014–N–2029]
announcing the availability of a draft provides answers to common questions Agency Information Collection
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guidance for industry on the that might arise about the mandatory Activities; Submission for Office of
implementation of the mandatory food recall provisions and FDA’s plans for Management and Budget Review;
recall provisions of the FDA Food Safety their implementation. Comment Request; Administrative
Modernization Act (FSMA). The This guidance is being issued
Practices and Procedures; Formal
guidance is in the form of Questions and consistent with our good guidance
Evidentiary Public Hearing
Answers and provides answers to practices regulation (21 CFR 10.115).
common questions that might arise The draft guidance, when finalized, will AGENCY: Food and Drug Administration,
about the mandatory recall provisions represent our current thinking on this HHS.

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Document Created: 2015-12-16 07:49:58
Document Modified: 2015-12-16 07:49:58

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		Although you may comment on any guidance at any time, to ensure that the Agency considers your comments on this draft guidance before it completes a final version of the guidance, submit electronic or written comments on the draft guidance by July 6, 2015.
Contact		Cecilia M. Wolyniak, Food and Drug Administration, WO32 Rm. 4352 HFC-210, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8209.
FR Citation		80 FR 26269

80 FR 26269 - Questions and Answers Regarding Mandatory Food Recalls; Draft Guidance for Industry

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration