81 FR 12907 - Acrylamide in Foods; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 48 (March 11, 2016)

Page Range		12907-12908
FR Document		2016-05490

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Acrylamide in Foods.'' The guidance finalizes the ``Draft Guidance for Industry on Acrylamide in Foods,'' modified where appropriate in response to comments we received on the draft guidance dated November 2013. This guidance is intended to provide information that may help growers, manufacturers, and food service operators reduce acrylamide levels in certain foods, which may mitigate potential human health risks from exposure to acrylamide.

Federal Register, Volume 81 Issue 48 (Friday, March 11, 2016)

[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12907-12908]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-05490]

[[Page 12907]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0715]

Acrylamide in Foods; Guidance for Industry; Availability

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 guidance for industry entitled ``Acrylamide in
Foods.'' The guidance finalizes the ``Draft Guidance for Industry on
Acrylamide in Foods,'' modified where appropriate in response to
comments we received on the draft guidance dated November 2013. This
guidance is intended to provide information that may help growers,
manufacturers, and food service operators reduce acrylamide levels in
certain foods, which may mitigate potential human health risks from
exposure to acrylamide.

DATES: Submit either electronic or written comments on FDA guidances 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-2013-D-0715] for the guidance document. 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 The
Division of Plant Products and Beverages, Office of Food Safety, 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.

FOR FURTHER INFORMATION CONTACT: Eileen Abt, Center for Food Safety and
Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740, 240-402-1529.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a guidance for industry
entitled ``Guidance for Industry: Acrylamide in Foods.'' We are issuing
this guidance consistent with our good guidance practices regulation
(21 CFR 10.115). The guidance represents 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. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
In the Federal Register of November 15, 2013, (78 FR 68852), we
made available a draft guidance for Industry entitled ``Draft Guidance
for Industry on Acrylamide in Foods'' and provided an opportunity for
comment prior to our work on the final version of the guidance. The
final guidance has been modified in response to comments. The guidance
announced in this notice finalizes the draft guidance dated November
2013.
This guidance is intended to provide information that may help
growers, manufacturers, and food service operators reduce acrylamide
levels in certain foods. Acrylamide is a chemical that can form in some
foods during certain types of high-temperature cooking. Acrylamide is a
concern because it can cause cancer in laboratory animals at high
doses, and is reasonably anticipated to be a human carcinogen. Reducing
acrylamide levels in foods may mitigate potential human health risks
from exposure to

[[Page 12908]]

acrylamide. The guidance is intended to suggest a range of possible
approaches to reducing acrylamide levels and not to identify specific
recommended approaches.

II. 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: March 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05490 Filed 3-10-16; 8:45 am]
BILLING CODE 4164-01-P

12908 Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices

acrylamide. The guidance is intended to Spring, MD 20993–0002, PRAStaff@ (LOA) from the existing IND holder that
suggest a range of possible approaches fda.hhs.gov. permits FDA to reference that IND.
to reducing acrylamide levels and not to Section 312.305(b) sets forth the
SUPPLEMENTARY INFORMATION: In submission requirements for all types of
identify specific recommended
compliance with 44 U.S.C. 3507, FDA expanded access requests. One of the
approaches.
has submitted the following proposed requirements under § 312.305(b)(2) is
II. Electronic Access collection of information to OMB for that a ‘‘cover sheet’’ must be included
Persons with access to the Internet review and clearance. ‘‘meeting the requirements of
may obtain the guidance at either Guidance for Industry on Individual § 312.23(a).’’ This provision applies to
http://www.fda.gov/FoodGuidances or Patient Expanded Access Applications: several types of submissions under 21
http://www.regulations.gov. Use the Form FDA 3926—OMB Control Number CFR part 312, ranging from commercial
FDA Web site listed in the previous 0910—NEW INDs under § 312.23 that involve large
sentence to find the most current groups of patients enrolled in clinical
version of the guidance. I. Background trials to requests from physicians to use
Dated: March 1, 2016. In the Federal Register of February an investigational drug for an individual
Leslie Kux, 10, 2015 (80 FR 7318), FDA announced patient. Form FDA 1571 is currently
the availability of a draft guidance for used by sponsors for all types of IND
Associate Commissioner for Policy.
industry entitled ‘‘Individual Patient submissions to meet the requirements in
[FR Doc. 2016–05490 Filed 3–10–16; 8:45 am]
Expanded Access Applications: Form § 312.23(a). FDA intends to accept
BILLING CODE 4164–01–P submission of a completed Form FDA
FDA 3926.’’ In the draft guidance, FDA
provided draft Form FDA 3926 3926 to comply with the IND
(Individual Patient Expanded Access— submission requirements in §§ 312.23,
DEPARTMENT OF HEALTH AND 312.305(b), and 312.310(b). FDA intends
HUMAN SERVICES Investigational New Drug Application
(IND)) at Appendix 1 and described this to consider a completed Form FDA 3926
Food and Drug Administration draft form, which FDA stated it with the box in Field 10 checked and
intended to make available for licensed the form signed by the physician to be
[Docket No. FDA–2015–D–0268] a request in accordance with § 312.10
physicians to use for expanded access
requests for individual patient INDs as for a waiver of any additional
Agency Information Collection requirements in part 312 for an IND
Activities; Submission for Office of an alternative to Form FDA 1571
(Investigational New Drug Application submission, including additional
Management and Budget Review; information currently provided in Form
Comment Request; Guidance for (IND)).
FDA 1571 and Form FDA 1572
Industry on Individual Patient As described in the final guidance,
(Statement of Investigator, which
Expanded Access Applications: Form Form FDA 3926 provides a streamlined
provides the identity and qualifications
FDA 3926 means to request expanded access to an
of the investigator conducting the
investigational drug outside of a clinical
AGENCY: Food and Drug Administration, clinical investigation).
investigation, or to an approved drug Under § 312.310(d), in an emergency
HHS. where availability is limited by a risk situation that requires the patient to be
ACTION: Notice. evaluation and mitigation strategy treated before a written submission can
(REMS), for an individual patient who be made, the request to use the
SUMMARY: The Food and Drug
has a serious or immediately life- investigational drug for individual
Administration (FDA) is announcing
threatening disease or condition and patient expanded access may be made
that a proposed collection of
there is no comparable or satisfactory by telephone (or other rapid means of
information has been submitted to the
alternative therapy to diagnose, monitor, communication) to the appropriate FDA
Office of Management and Budget
or treat the disease or condition. Form review division. Authorization of the
(OMB) for review and clearance under
FDA 3926 may also be used for certain emergency use may be given by an FDA
the Paperwork Reduction Act of 1995.
followup submissions to an individual official over the telephone, provided the
DATES: Fax written comments on the patient expanded access IND.
collection of information by April 11, physician explains how the expanded
FDA may permit expanded access to access use will meet the requirements of
2016. an investigational new drug outside of §§ 312.305 and 312.310 and agrees to
ADDRESSES: To ensure that comments on a clinical investigation, or to an submit an expanded access application
the information collection are received, approved drug where availability is within 15 working days of FDA’s initial
OMB recommends that written limited by a REMS, for an individual authorization of the expanded access
comments be faxed to the Office of patient when the applicable criteria in use (§ 312.310(d)). The physician may
Information and Regulatory Affairs, § 312.305(a) (21 CFR 312.305(a)) (which choose to use Form FDA 3926 for the
OMB, Attn: FDA Desk Officer, FAX: apply to all types of expanded access) expanded access application.
202–395–7285, or emailed to oira_ and the criteria in § 312.310(a) (21 CFR As explained in the instructions for
submission@omb.eop.gov. All 312.310(a)) (which apply specifically to Form FDA 3926, the following
comments should be identified with the individual patient expanded access, information would be submitted to FDA
OMB control number 0910–New and including for emergency use) are met. by those using Form FDA 3926:
title ‘‘Individual Patient Expanded The physician may satisfy some of the • Initials for the patient and date of
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Access Applications: Form FDA 3926.’’ submission requirements by referring to submission.
Also include the FDA docket number information in an existing IND, • Type of submission (initial or
found in brackets in the heading of this ordinarily the one held by the followup submission).
document. investigational drug’s manufacturer, if • Clinical information, including
FOR FURTHER INFORMATION CONTACT: FDA the physician obtains permission from indication, brief clinical history of the
PRA Staff, Office of Operations, Food that IND holder. If permission is patient (age, gender, weight, allergies,
and Drug Administration, 8455 obtained, the physician should then diagnosis, prior therapy, response to
Colesville Rd., COLE–14526, Silver provide to FDA a letter of authorization prior therapy), and the reason for

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Document Created: 2016-03-11 01:51:03
Document Modified: 2016-03-11 01:51:03

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 FDA guidances at any time.
Contact		Eileen Abt, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1529.
FR Citation		81 FR 12907

81 FR 12907 - Acrylamide in Foods; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 48 (March 11, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration