Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability, 58618-58619 [2017-26828]
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58618
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
needed. In addition to this statutorily
required annual notice, FDA intends to
publish a Federal Register notice within
the next few months to allow for public
comment on the initial recognition of
susceptibility test interpretive criteria.
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26790 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6352]
Gluten in Drug Products and
Associated Labeling
Recommendations; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Gluten
in Drug Products and Associated
Labeling Recommendations.’’ This draft
guidance is intended to convey to drug
manufacturers FDA’s recommendations
on how certain oral drug products
should be labeled regarding gluten, a
matter of interest to individuals with
celiac disease. Some individuals with
celiac disease have faced difficulty
when trying to determine whether
specific drug products contain gluten.
This draft guidance encourages drug
manufacturers to have accurate
information about their products’ gluten
content available so they can respond to
questions from consumers and health
care professionals.
DATES: Submit either electronic or
written comments on the draft guidance
by February 12, 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draft guidance before it begins work on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
on any guidance at any time as follows:
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
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 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–
2017–D–6352 for ‘‘Gluten in Drug
Products and Associated Labeling
Recommendations.’’ 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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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/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
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. 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:
Marci Kiester, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2258,
Silver Spring, MD 20993–0002, 301–
796–0600; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Gluten in Drug Products and
Associated Labeling
E:\FR\FM\13DEN1.SGM
13DEN1
Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
Recommendations.’’ This draft guidance
is intended to convey to drug
manufacturers FDA’s recommendations
on how certain drug products should be
labeled regarding gluten, a matter of
interest to individuals with celiac
disease. Some individuals with celiac
disease have faced difficulty when
trying to determine whether specific
drug products contain gluten.
Confronted by uncertainty, some
patients may forego important
medication rather than risk an adverse
reaction to gluten. Thus, even if gluten
is not present at levels that would harm
a typical individual with celiac disease,
that individual may be harmed through
uncertainty and lack of information.
Celiac disease is an immune-based
reaction to dietary gluten that primarily
affects the small intestine in susceptible
individuals; unmanaged celiac disease
can lead to serious health
complications. Approximately 1 percent
of the U.S. population has celiac disease
(Binder, 2015, ‘‘Disorders of
Absorption,’’ in Harrison’s Principles of
Internal Medicine, 19th ed.). It is
characterized by ongoing inflammation
of part of the lining of the small
intestine that generally heals if foods
containing gluten are excluded from the
diet and returns if they are
reintroduced. This guidance encourages
drug manufacturers to have accurate
information about their products’ gluten
content available so they can respond to
questions from consumers and health
care professionals. Manufacturers
should pay attention to possible sources
of gluten in their products, consider
specifications when appropriate, and
consider the impact of changes in
ingredient sources or formulations on
gluten content.
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
on Gluten in Drug Products and
Associated Labeling Recommendations.
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 guidance is not subject
to Executive Order 12866.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information that 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). The
collections of information discussed in
VerDate Sep<11>2014
18:53 Dec 12, 2017
Jkt 244001
the draft guidance have been approved
by OMB under the following control
numbers:
OMB control number 0910–0001:
Submitting to FDA labeling in NDAs
and ANDAs, including amendments to
pending NDAs and ANDAs,
supplements to approved NDAs and
ANDAs, and annual reports; OMB
control number 0910–0572: Designing,
testing, and revising prescription drug
product labeling; OMB control number
0910–0340: Designing, testing, and
revising Drug Facts labeling for OTC
drugs, including submitting labeling to
FDA for OTC monograph drugs; OMB
control number 0910–0139:
Recordkeeping requirements in CGMPs;
OMB control number 0910–0393:
Preparing and revising Medication
Guides; and OMB control number 0910–
0338: Submitting to FDA labeling in
BLAs, including amendments to
pending BLAs, supplements to
approved BLAs, and annual reports.
The recommended labeling statement
in this draft guidance, ‘‘Contains no
ingredient made from a glutencontaining grain (wheat, barley, or rye)’’
is information provided by FDA to
applicants and manufacturers for
disclosure to the public and therefore
does not constitute a collection of
information under 5 CFR 1320.3(c)(2).
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26828 Filed 12–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6455]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Consultation Procedures: Foods
Derived From New Plant Varieties
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00032
Fmt 4703
Sfmt 4703
58619
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s
consultation procedures for foods
derived from new plant varieties,
including the information collection
provisions in the guidance entitled,
‘‘Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties,’’ and in Form FDA 3665
entitled, ‘‘Final Consultation For Food
Derived From a New Plant Variety
(Biotechnology Final Consultation),’’
which developers may use to prepare
the final consultation in a standard
format.
DATES: Submit either electronic or
written comments on the collection of
information by February 12, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 12,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 12, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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,
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
E:\FR\FM\13DEN1.SGM
13DEN1
Agencies
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58618-58619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26828]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6352]
Gluten in Drug Products and Associated Labeling Recommendations;
Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Gluten in
Drug Products and Associated Labeling Recommendations.'' This draft
guidance is intended to convey to drug manufacturers FDA's
recommendations on how certain oral drug products should be labeled
regarding gluten, a matter of interest to individuals with celiac
disease. Some individuals with celiac disease have faced difficulty
when trying to determine whether specific drug products contain gluten.
This draft guidance encourages drug manufacturers to have accurate
information about their products' gluten content available so they can
respond to questions from consumers and health care professionals.
DATES: Submit either electronic or written comments on the draft
guidance by February 12, 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 on any guidance at any time 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, 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-2017-D-6352 for ``Gluten in Drug Products and Associated Labeling
Recommendations.'' 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 Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 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: Marci Kiester, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2258, Silver Spring, MD 20993-0002, 301-
796-0600; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Gluten in Drug Products and Associated Labeling
[[Page 58619]]
Recommendations.'' This draft guidance is intended to convey to drug
manufacturers FDA's recommendations on how certain drug products should
be labeled regarding gluten, a matter of interest to individuals with
celiac disease. Some individuals with celiac disease have faced
difficulty when trying to determine whether specific drug products
contain gluten. Confronted by uncertainty, some patients may forego
important medication rather than risk an adverse reaction to gluten.
Thus, even if gluten is not present at levels that would harm a typical
individual with celiac disease, that individual may be harmed through
uncertainty and lack of information.
Celiac disease is an immune-based reaction to dietary gluten that
primarily affects the small intestine in susceptible individuals;
unmanaged celiac disease can lead to serious health complications.
Approximately 1 percent of the U.S. population has celiac disease
(Binder, 2015, ``Disorders of Absorption,'' in Harrison's Principles of
Internal Medicine, 19th ed.). It is characterized by ongoing
inflammation of part of the lining of the small intestine that
generally heals if foods containing gluten are excluded from the diet
and returns if they are reintroduced. This guidance encourages drug
manufacturers to have accurate information about their products' gluten
content available so they can respond to questions from consumers and
health care professionals. Manufacturers should pay attention to
possible sources of gluten in their products, consider specifications
when appropriate, and consider the impact of changes in ingredient
sources or formulations on gluten content.
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 on Gluten in Drug
Products and Associated Labeling Recommendations. 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 guidance is not subject to
Executive Order 12866.
II. The Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information that 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). The collections of information discussed in the draft guidance
have been approved by OMB under the following control numbers:
OMB control number 0910-0001: Submitting to FDA labeling in NDAs
and ANDAs, including amendments to pending NDAs and ANDAs, supplements
to approved NDAs and ANDAs, and annual reports; OMB control number
0910-0572: Designing, testing, and revising prescription drug product
labeling; OMB control number 0910-0340: Designing, testing, and
revising Drug Facts labeling for OTC drugs, including submitting
labeling to FDA for OTC monograph drugs; OMB control number 0910-0139:
Recordkeeping requirements in CGMPs; OMB control number 0910-0393:
Preparing and revising Medication Guides; and OMB control number 0910-
0338: Submitting to FDA labeling in BLAs, including amendments to
pending BLAs, supplements to approved BLAs, and annual reports.
The recommended labeling statement in this draft guidance,
``Contains no ingredient made from a gluten-containing grain (wheat,
barley, or rye)'' is information provided by FDA to applicants and
manufacturers for disclosure to the public and therefore does not
constitute a collection of information under 5 CFR 1320.3(c)(2).
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.
Dated: December 7, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26828 Filed 12-12-17; 8:45 am]
BILLING CODE 4164-01-P