Document ID: FDA-2017-D-6352-0001
Agency: fda
Document Type: Notice
Title: Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability
Posted Date: 2017-12-13T05:00Z

[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]

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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Draft Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry entitled ``Gluten in 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 This draft 
guidance is intended to convey to drug manufacturers FDA's 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This draft guidance encourages drug manufacturers to have accurate 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DATES: Submit either electronic or written comments on the draft 
guidance by February 12, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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