83 FR 42306 - Quality Attribute Considerations for Chewable Tablets; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 162 (August 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 162 (August 21, 2018)
| Page Range | 42306-42307 | |
| FR Document | 2018-17967 |
[Federal Register Volume 83, Number 162 (Tuesday, August 21, 2018)] [Notices] [Pages 42306-42307] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17967] [[Page 42306]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-1490] Quality Attribute Considerations for Chewable Tablets; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Quality Attribute Considerations for Chewable Tablets.'' This guidance finalizes the draft guidance issued June 16, 2016, which provides manufacturers of chewable tablets for human use with the Center for Drug Evaluation and Research's current thinking on the critical quality attributes that should be assessed during the development of these drug products. DATES: The announcement of the guidance is published in the Federal Register on August 21, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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-2016-D-1490 for ``Quality Attribute Considerations for Chewable Tablets.'' 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 this 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. Send one self- addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Nallaperumal Chidambaram, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1339. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ``Quality Attribute Considerations for Chewable Tablets.'' Chewable tablets are an immediate release oral dosage form intended to be chewed and then swallowed by the patient, rather than swallowed whole. This guidance describes the critical quality attributes that should be considered when developing chewable tablet dosage forms and recommends that the selected acceptance criteria be appropriate and meaningful indicators of product performance throughout the shelf life of the product. This guidance finalizes the draft guidance issued June 16, 2016, (81 FR 39673) which described the Chewing Difficulty Index (CDI), a new quality attribute concept that was developed internally and findings were published in a peer reviewed journal. We received comments primarily seeking clarity how this new parameter would be assessed during regulatory review. The Agency provided additional clarifications in this guidance whereby sponsors and/or applicants would accrue CDI data during drug product development and submit it in their applications. We intend to evaluate the data to inform future guidance on this topic, as needed. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Quality Attribute [[Page 42307]] Considerations for Chewable Tablets.'' 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. Paperwork Reduction Act of 1995 This 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 collection of information in investigational new drug applications is approved by OMB under control number 0910-0014; the collection of information (including prescription drug labeling) in new drug applications and abbreviated new drug applications, as well as supplements to these applications, is approved by OMB under control number 0910-0001; the collection of biologics license applications is approved by OMB under control number 0910-0338; and the format and content of prescription drug labeling is approved by OMB under control number 0910-0572. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: August 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17967 Filed 8-20-18; 8:45 am] BILLING CODE 4164-01-P
![42306 Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices
DEPARTMENT OF HEALTH AND Written/Paper Submissions docket number, found in brackets in the
HUMAN SERVICES Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
Food and Drug Administration • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
[Docket No. FDA–2016–D–1490] Management Staff (HFA–305), Food and Rockville, MD 20852.
Drug Administration, 5630 Fishers You may submit comments on any
Quality Attribute Considerations for Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
Chewable Tablets; Guidance for • For written/paper comments 10.115(g)(5)).
Industry; Availability submitted to the Dockets Management Submit written requests for single
Staff, FDA will post your comment, as copies of this guidance to the Division
AGENCY: Food and Drug Administration, of Drug Information, Center for Drug
HHS. well as any attachments, except for
information submitted, marked and Evaluation and Research, Food and
ACTION: Notice of availability. identified, as confidential, if submitted Drug Administration, 10001 New
as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
SUMMARY: The Food and Drug 4th Floor, Silver Spring, MD 20993–
Administration (FDA, Agency, or we) is Instructions: All submissions received
must include the Docket No. FDA– 0002. Send one self-addressed adhesive
announcing the availability of a final label to assist that office in processing
guidance for industry entitled ‘‘Quality 2016–D–1490 for ‘‘Quality Attribute
Considerations for Chewable Tablets.’’ your requests. See the SUPPLEMENTARY
Attribute Considerations for Chewable INFORMATION section for electronic
Tablets.’’ This guidance finalizes the Received comments will be placed in
the docket and, except for those access to the guidance document.
draft guidance issued June 16, 2016,
submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
which provides manufacturers of
Submissions,’’ publicly viewable at Nallaperumal Chidambaram, Center for
chewable tablets for human use with the
https://www.regulations.gov or at the Drug Evaluation and Research, Food
Center for Drug Evaluation and
Dockets Management Staff between 9 and Drug Administration, 10903 New
Research’s current thinking on the
a.m. and 4 p.m., Monday through Hampshire Ave., Silver Spring, MD
critical quality attributes that should be
Friday. 20993–0002, 301–796–1339.
assessed during the development of
these drug products. • Confidential Submissions—To SUPPLEMENTARY INFORMATION:
submit a comment with confidential
DATES: The announcement of the information that you do not wish to be I. Background
guidance is published in the Federal made publicly available, submit your FDA is announcing the availability of
Register on August 21, 2018. comments only as a written/paper a guidance for industry entitled
ADDRESSES: You may submit either submission. You should submit two ‘‘Quality Attribute Considerations for
electronic or written comments on copies total. One copy will include the Chewable Tablets.’’ Chewable tablets are
Agency guidances at any time as information you claim to be confidential an immediate release oral dosage form
follows: with a heading or cover note that states intended to be chewed and then
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS swallowed by the patient, rather than
CONFIDENTIAL INFORMATION.’’ The swallowed whole. This guidance
Submit electronic comments in the Agency will review this copy, including describes the critical quality attributes
following way: the claimed confidential information, in that should be considered when
• Federal eRulemaking Portal: its consideration of comments. The developing chewable tablet dosage
https://www.regulations.gov. Follow the second copy, which will have the forms and recommends that the selected
instructions for submitting comments. claimed confidential information acceptance criteria be appropriate and
Comments submitted electronically, redacted/blacked out, will be available meaningful indicators of product
including attachments, to https:// for public viewing and posted on performance throughout the shelf life of
www.regulations.gov will be posted to https://www.regulations.gov. Submit the product.
the docket unchanged. Because your both copies to the Dockets Management This guidance finalizes the draft
comment will be made public, you are Staff. If you do not wish your name and guidance issued June 16, 2016, (81 FR
solely responsible for ensuring that your contact information to be made publicly 39673) which described the Chewing
comment does not include any available, you can provide this Difficulty Index (CDI), a new quality
confidential information that you or a information on the cover sheet and not attribute concept that was developed
third party may not wish to be posted, in the body of your comments and you internally and findings were published
such as medical information, your or must identify this information as in a peer reviewed journal. We received
anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked comments primarily seeking clarity how
confidential business information, such as ‘‘confidential’’ will not be disclosed this new parameter would be assessed
as a manufacturing process. Please note except in accordance with 21 CFR 10.20 during regulatory review. The Agency
that if you include your name, contact and other applicable disclosure law. For provided additional clarifications in this
information, or other information that more information about FDA’s posting guidance whereby sponsors and/or
identifies you in the body of your of comments to public dockets, see 80 applicants would accrue CDI data
comments, that information will be FR 56469, September 18, 2015, or access during drug product development and
posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ submit it in their applications. We
sradovich on DSK3GMQ082PROD with NOTICES
• If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- intend to evaluate the data to inform
with confidential information that you 23389.pdf. future guidance on this topic, as needed.
do not wish to be made available to the Docket: For access to the docket to This guidance is being issued
public, submit the comment as a read background documents or the consistent with FDA’s good guidance
written/paper submission and in the electronic and written/paper comments practices regulation (21 CFR 10.115).
manner detailed (see ‘‘Written/Paper received, go to https:// The guidance represents the current
Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the thinking of FDA on ‘‘Quality Attribute
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![Federal Register / Vol. 83, No. 162 / Tuesday, August 21, 2018 / Notices 42307
Considerations for Chewable Tablets.’’ It radiopharmaceutical diagnostic drugs Received comments will be placed in
does not establish any rights for any on the nonclinical studies the docket and, except for those
person and is not binding on FDA or the recommended to support human submitted as ‘‘Confidential
public. You can use an alternative clinical trials and marketing Submissions,’’ publicly viewable at
approach if it satisfies the requirements applications. This guidance finalizes the https://www.regulations.gov or at the
of the applicable statutes and draft guidance of the same name issued Dockets Management Staff between 9
regulations. This guidance is not subject on September 13, 2017. a.m. and 4 p.m., Monday through
to Executive Order 12866. DATES: The announcement of the Friday.
II. Paperwork Reduction Act of 1995 guidance is published in the Federal • Confidential Submissions—To
Register on August 21, 2018. submit a comment with confidential
This guidance refers to previously information that you do not wish to be
approved collections of information that ADDRESSES: You may submit either
electronic or written comments on made publicly available, submit your
are subject to review by the Office of comments only as a written/paper
Management and Budget (OMB) under Agency guidances at any time as
follows: submission. You should submit two
the Paperwork Reduction Act of 1995 copies total. One copy will include the
(44 U.S.C. 3501–3520). The collection of Electronic Submissions information you claim to be confidential
information in investigational new drug with a heading or cover note that states
applications is approved by OMB under Submit electronic comments in the
following way: ‘‘THIS DOCUMENT CONTAINS
control number 0910–0014; the CONFIDENTIAL INFORMATION.’’ The
collection of information (including • Federal eRulemaking Portal:
https://www.regulations.gov. Follow the Agency will review this copy, including
prescription drug labeling) in new drug the claimed confidential information, in
applications and abbreviated new drug instructions for submitting comments.
Comments submitted electronically, its consideration of comments. The
applications, as well as supplements to second copy, which will have the
these applications, is approved by OMB including attachments, to https://
www.regulations.gov will be posted to claimed confidential information
under control number 0910–0001; the redacted/blacked out, will be available
collection of biologics license the docket unchanged. Because your
comment will be made public, you are for public viewing and posted on
applications is approved by OMB under https://www.regulations.gov. Submit
control number 0910–0338; and the solely responsible for ensuring that your
comment does not include any both copies to the Dockets Management
format and content of prescription drug Staff. If you do not wish your name and
labeling is approved by OMB under confidential information that you or a
third party may not wish to be posted, contact information to be made publicly
control number 0910–0572. available, you can provide this
such as medical information, your or
III. Electronic Access anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Persons with access to the internet
as a manufacturing process. Please note must identify this information as
may obtain the guidance at either
that if you include your name, contact ‘‘confidential.’’ Any information marked
https://www.fda.gov/Drugs/Guidance
information, or other information that as ‘‘confidential’’ will not be disclosed
ComplianceRegulatoryInformation/
identifies you in the body of your except in accordance with 21 CFR 10.20
Guidances/default.htm or https://
comments, that information will be and other applicable disclosure law. For
www.regulations.gov.
posted on https://www.regulations.gov. more information about FDA’s posting
Dated: August 15, 2018. of comments to public dockets, see 80
• If you want to submit a comment
Leslie Kux, FR 56469, September 18, 2015, or access
with confidential information that you
Associate Commissioner for Policy. do not wish to be made available to the the information at: https://www.gpo.gov/
[FR Doc. 2018–17967 Filed 8–20–18; 8:45 am] public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
BILLING CODE 4164–01–P written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
DEPARTMENT OF HEALTH AND electronic and written/paper comments
HUMAN SERVICES Written/Paper Submissions received, go to https://
Submit written/paper submissions as www.regulations.gov and insert the
Food and Drug Administration docket number, found in brackets in the
follows:
[Docket No. FDA–2017–D–5297] • Mail/Hand delivery/Courier (for heading of this document, into the
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Microdose Radiopharmaceutical Management Staff (HFA–305), Food and and/or go to the Dockets Management
Diagnostic Drugs: Nonclinical Study Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Recommendations; Guidance for Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
Industry; Availability • For written/paper comments You may submit comments on any
AGENCY: Food and Drug Administration, submitted to the Dockets Management guidance at any time (see 21 CFR
HHS. Staff, FDA will post your comment, as 10.115(g)(5)).
ACTION: Notice of availability. well as any attachments, except for Submit written requests for single
information submitted, marked and copies of this guidance to the Division
SUMMARY: The Food and Drug identified, as confidential, if submitted of Drug Information, Center for Drug
sradovich on DSK3GMQ082PROD with NOTICES
Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’ Evaluation and Research, Food and
announcing the availability of a final Instructions: All submissions received Drug Administration, 10001 New
guidance for industry entitled must include the Docket No. FDA– Hampshire Ave., Hillandale Building,
‘‘Microdose Radiopharmaceutical 2017–D–5297 for ‘‘Microdose 4th Floor, Silver Spring, MD 20993–
Diagnostic Drugs: Nonclinical Study Radiopharmaceutical Diagnostic Drugs: 0002. Send one self-addressed adhesive
Recommendations.’’ This guidance is Nonclinical Study Recommendations; label to assist that office in processing
intended to assist sponsors of microdose Guidance for Industry; Availability.’’ your requests. See the SUPPLEMENTARY
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Document Created: 2018-08-21 00:07:16
Document Modified: 2018-08-21 00:07:16
| 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 | The announcement of the guidance is published in the Federal Register on August 21, 2018. | |
| Contact | Nallaperumal Chidambaram, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1339. | |
| FR Citation | 83 FR 42306 |
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