82 FR 58618 - Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 238 (December 13, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 238 (December 13, 2017)
| Page Range | 58618-58619 | |
| FR Document | 2017-26828 |
[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)] [Notices] [Pages 58618-58619] From the Federal Register Online [www.thefederalregister.org] [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and Drug Administration [Docket No. FDA-2017-D-6352] Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Gluten in Drug Products and Associated Labeling Recommendations.'' This draft guidance is intended to convey to drug manufacturers FDA's recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to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 This draft guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and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 DATES: Submit either electronic or written comments on the draft guidance by February 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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
![58618 Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices
needed. In addition to this statutorily comment will be made public, you are Staff. If you do not wish your name and
required annual notice, FDA intends to solely responsible for ensuring that your contact information to be made publicly
publish a Federal Register notice within comment does not include any available, you can provide this
the next few months to allow for public confidential information that you or a information on the cover sheet and not
comment on the initial recognition of third party may not wish to be posted, in the body of your comments and you
susceptibility test interpretive criteria. such as medical information, your or must identify this information as
Dated: December 7, 2017. anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked
confidential business information, such as ‘‘confidential’’ will not be disclosed
Leslie Kux,
as a manufacturing process. Please note except in accordance with 21 CFR 10.20
Associate Commissioner for Policy.
that if you include your name, contact and other applicable disclosure law. For
[FR Doc. 2017–26790 Filed 12–12–17; 8:45 am] information, or other information that more information about FDA’s posting
BILLING CODE 4164–01–P identifies you in the body of your of comments to public dockets, see 80
comments, that information will be FR 56469, September 18, 2015, or access
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/
DEPARTMENT OF HEALTH AND • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015-
HUMAN SERVICES with confidential information that you 23389.pdf.
do not wish to be made available to the Docket: For access to the docket to
Food and Drug Administration public, submit the comment as a read background documents or the
[Docket No. FDA–2017–D–6352] written/paper submission and in the electronic and written/paper comments
manner detailed (see ‘‘Written/Paper received, go to https://
Gluten in Drug Products and Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the
Associated Labeling docket number, found in brackets in the
Recommendations; Draft Guidance for Written/Paper Submissions
heading of this document, into the
Industry; Availability Submit written/paper submissions as ‘‘Search’’ box and follow the prompts
follows:
AGENCY: Food and Drug Administration, and/or go to the Dockets Management
• Mail/Hand delivery/Courier (for
HHS. Staff, 5630 Fishers Lane, Rm. 1061,
written/paper submissions): Dockets
ACTION: Notice of availability. Rockville, MD 20852.
Management Staff (HFA–305), Food and
You may submit comments on any
Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug guidance at any time (see 21 CFR
Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or Agency) is • For written/paper comments 10.115(g)(5)).
announcing the availability of a draft submitted to the Dockets Management Submit written requests for single
guidance for industry entitled ‘‘Gluten Staff, FDA will post your comment, as copies of the draft guidance to the
in Drug Products and Associated well as any attachments, except for Division of Drug Information, Center for
Labeling Recommendations.’’ This draft information submitted, marked and Drug Evaluation and Research, Food
guidance is intended to convey to drug identified, as confidential, if submitted and Drug Administration, 10001 New
manufacturers FDA’s recommendations as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
on how certain oral drug products Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
should be labeled regarding gluten, a must include the Docket No. FDA– 0002; or to the Office of
matter of interest to individuals with 2017–D–6352 for ‘‘Gluten in Drug Communication, Outreach and
celiac disease. Some individuals with Products and Associated Labeling Development, Center for Biologics
celiac disease have faced difficulty Recommendations.’’ Received Evaluation and Research, Food and
when trying to determine whether comments will be placed in the docket Drug Administration, 10903 New
specific drug products contain gluten. and, except for those submitted as Hampshire Ave., Bldg. 71, Rm. 3128,
This draft guidance encourages drug ‘‘Confidential Submissions,’’ publicly Silver Spring, MD 20993–0002. Send
manufacturers to have accurate viewable at https://www.regulations.gov one self-addressed adhesive label to
information about their products’ gluten or at the Dockets Management Staff assist that office in processing your
content available so they can respond to between 9 a.m. and 4 p.m., Monday requests. See the SUPPLEMENTARY
questions from consumers and health through Friday. INFORMATION section for electronic
care professionals. • Confidential Submissions—To access to the draft guidance document.
DATES: Submit either electronic or submit a comment with confidential FOR FURTHER INFORMATION CONTACT:
written comments on the draft guidance information that you do not wish to be Marci Kiester, Center for Drug
by February 12, 2018 to ensure that the made publicly available, submit your Evaluation and Research, Food and
Agency considers your comment on this comments only as a written/paper Drug Administration, 10903 New
draft guidance before it begins work on submission. You should submit two Hampshire Ave., Bldg. 51, Rm. 2258,
the final version of the guidance. copies total. One copy will include the Silver Spring, MD 20993–0002, 301–
ADDRESSES: You may submit comments information you claim to be confidential 796–0600; or Stephen Ripley, Center for
on any guidance at any time as follows: with a heading or cover note that states Biologics Evaluation and Research,
‘‘THIS DOCUMENT CONTAINS Food and Drug Administration, 10903
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The New Hampshire Ave., Bldg. 71, Rm.
Submit electronic comments in the Agency will review this copy, including 7301, Silver Spring, MD 20993–0002,
following way: the claimed confidential information, in 240–402–7911.
sradovich on DSK3GMQ082PROD with NOTICES
• Federal eRulemaking Portal: its consideration of comments. The SUPPLEMENTARY INFORMATION:
https://www.regulations.gov. Follow the second copy, which will have the
instructions for submitting comments. claimed confidential information I. Background
Comments submitted electronically, redacted/blacked out, will be available FDA is announcing the availability of
including attachments, to https:// for public viewing and posted on a draft guidance for industry entitled
www.regulations.gov will be posted to https://www.regulations.gov. Submit ‘‘Gluten in Drug Products and
the docket unchanged. Because your both copies to the Dockets Management Associated Labeling
VerDate Sep<11>2014 18:53 Dec 12, 2017 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1](https://thefederalregister.org/doc/82_FR_58856/page/1.svg)
![Federal Register / Vol. 82, No. 238 / Wednesday, December 13, 2017 / Notices 58619
Recommendations.’’ This draft guidance the draft guidance have been approved SUMMARY: The Food and Drug
is intended to convey to drug by OMB under the following control Administration (FDA or Agency) is
manufacturers FDA’s recommendations numbers: announcing an opportunity for public
on how certain drug products should be OMB control number 0910–0001: comment on the proposed collection of
labeled regarding gluten, a matter of Submitting to FDA labeling in NDAs certain information by the Agency.
interest to individuals with celiac and ANDAs, including amendments to Under the Paperwork Reduction Act of
disease. Some individuals with celiac pending NDAs and ANDAs, 1995 (PRA), Federal Agencies are
disease have faced difficulty when supplements to approved NDAs and required to publish notice in the
trying to determine whether specific ANDAs, and annual reports; OMB Federal Register concerning each
drug products contain gluten. control number 0910–0572: Designing, proposed collection of information,
Confronted by uncertainty, some testing, and revising prescription drug including each proposed extension of an
patients may forego important product labeling; OMB control number existing collection of information, and
medication rather than risk an adverse 0910–0340: Designing, testing, and to allow 60 days for public comment in
reaction to gluten. Thus, even if gluten revising Drug Facts labeling for OTC response to the notice. This notice
is not present at levels that would harm drugs, including submitting labeling to solicits comments on the information
a typical individual with celiac disease, FDA for OTC monograph drugs; OMB collection provisions of FDA’s
that individual may be harmed through control number 0910–0139: consultation procedures for foods
uncertainty and lack of information. Recordkeeping requirements in CGMPs; derived from new plant varieties,
Celiac disease is an immune-based OMB control number 0910–0393: including the information collection
reaction to dietary gluten that primarily Preparing and revising Medication provisions in the guidance entitled,
affects the small intestine in susceptible Guides; and OMB control number 0910– ‘‘Guidance on Consultation Procedures:
individuals; unmanaged celiac disease 0338: Submitting to FDA labeling in Foods Derived From New Plant
can lead to serious health BLAs, including amendments to Varieties,’’ and in Form FDA 3665
complications. Approximately 1 percent pending BLAs, supplements to entitled, ‘‘Final Consultation For Food
of the U.S. population has celiac disease approved BLAs, and annual reports. Derived From a New Plant Variety
(Binder, 2015, ‘‘Disorders of The recommended labeling statement (Biotechnology Final Consultation),’’
Absorption,’’ in Harrison’s Principles of in this draft guidance, ‘‘Contains no which developers may use to prepare
Internal Medicine, 19th ed.). It is ingredient made from a gluten- the final consultation in a standard
characterized by ongoing inflammation containing grain (wheat, barley, or rye)’’ format.
of part of the lining of the small is information provided by FDA to
intestine that generally heals if foods DATES: Submit either electronic or
applicants and manufacturers for written comments on the collection of
containing gluten are excluded from the disclosure to the public and therefore
diet and returns if they are information by February 12, 2018.
does not constitute a collection of ADDRESSES: You may submit comments
reintroduced. This guidance encourages information under 5 CFR 1320.3(c)(2).
drug manufacturers to have accurate as follows. Please note that late,
information about their products’ gluten III. Electronic Access untimely filed comments will not be
content available so they can respond to considered. Electronic comments must
Persons with access to the internet
questions from consumers and health be submitted on or before February 12,
may obtain the draft guidance at either
care professionals. Manufacturers 2018. The https://www.regulations.gov
https://www.fda.gov/Drugs/Guidance
should pay attention to possible sources electronic filing system will accept
ComplianceRegulatoryInformation/
of gluten in their products, consider comments until midnight Eastern Time
Guidances/default.htm, https://
specifications when appropriate, and at the end of February 12, 2018.
www.fda.gov/BiologicsBloodVaccines/
consider the impact of changes in Comments received by mail/hand
GuidanceComplianceRegulatory
ingredient sources or formulations on delivery/courier (for written/paper
Information/default.htm, or https://
gluten content. submissions) will be considered timely
www.regulations.gov.
This draft guidance is being issued if they are postmarked or the delivery
consistent with FDA’s good guidance Dated: December 7, 2017. service acceptance receipt is on or
practices regulation (21 CFR 10.115). Leslie Kux, before that date.
The draft guidance, when finalized, will Associate Commissioner for Policy.
Electronic Submissions
represent the current thinking of FDA [FR Doc. 2017–26828 Filed 12–12–17; 8:45 am]
on Gluten in Drug Products and BILLING CODE 4164–01–P
Submit electronic comments in the
Associated Labeling Recommendations. following way:
It does not establish any rights for any • Federal eRulemaking Portal:
person and is not binding on FDA or the DEPARTMENT OF HEALTH AND https://www.regulations.gov. Follow the
public. You can use an alternative HUMAN SERVICES instructions for submitting comments.
approach if it satisfies the requirements Comments submitted electronically,
of the applicable statutes and Food and Drug Administration including attachments, to https://
regulations. This guidance is not subject www.regulations.gov will be posted to
to Executive Order 12866. [Docket No. FDA–2017–N–6455] the docket unchanged. Because your
comment will be made public, you are
II. The Paperwork Reduction Act of Agency Information Collection solely responsible for ensuring that your
1995 Activities; Proposed Collection; comment does not include any
sradovich on DSK3GMQ082PROD with NOTICES
This draft guidance refers to Comment Request; Guidance on confidential information that you or a
previously approved collections of Consultation Procedures: Foods third party may not wish to be posted,
information that are subject to review by Derived From New Plant Varieties such as medical information, your or
the Office of Management and Budget AGENCY: Food and Drug Administration, anyone else’s Social Security number, or
(OMB) under the Paperwork Reduction HHS. confidential business information, such
Act of 1995 (44 U.S.C. 3501–3520). The as a manufacturing process. Please note
ACTION: Notice.
collections of information discussed in that if you include your name, contact
VerDate Sep<11>2014 18:53 Dec 12, 2017 Jkt 244001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\13DEN1.SGM 13DEN1](https://thefederalregister.org/doc/82_FR_58856/page/2.svg)
Document Created: 2017-12-13 01:23:52
Document Modified: 2017-12-13 01:23:52
| 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 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. | |
| 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. | |
| FR Citation | 82 FR 58618 |
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