Document ID: FDA-2018-D-1098-0001
Agency: fda
Document Type: Notice
Title: Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality
Considerations; Draft Guidance for Industry
Posted Date: 2018-04-19T04:00Z

[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Notices]
[Pages 17420-17421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08200]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1098]

Metered Dose Inhaler and Dry Powder Inhaler Drug Products--
Quality Considerations; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Metered 
Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality 
Considerations.'' The purpose of this guidance is to provide 
recommendations to industry on the development and manufacture of 
inhalation aerosols (also known as metered dose inhalers, or MDIs) and 
inhalation powders (also known as dry powder inhalers, or DPIs). 
Although not explicitly discussed, some of the principles and 
recommendations provided in this guidance may be applicable to nasal 
delivery products, as well. The recommendations in this guidance can 
apply to MDI and DPI products intended for local or systemic effect.

DATES: Submit either electronic or written comments on the draft 
guidance by June 18, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2018-D-1098 for ``Metered Dose Inhaler (MDI) and Dry Powder Inhaler 
(DPI) Drug Products--Quality Considerations.'' 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. 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: Richard Lostritto, Center for Drug

[[Page 17421]]

Evaluation and Research, (HFD-860), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-
796-1697.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug 
Products--Quality Considerations.'' This guidance describes points to 
consider to help ensure product quality and performance for MDIs and 
DPIs. It describes chemistry, manufacturing, and controls information 
recommended for inclusion in new drug applications (NDAs) and 
abbreviated new drug applications (ANDAs); however, the principles are 
applicable to products used during clinical trials and over the product 
lifecycle, as well. It also provides recommendations on certain aspects 
of labeling for NDA and ANDA MDI and DPI products. FDA previously 
published a draft guidance on this topic on November 13, 1998. The 
present guidance is a revision of the previous draft, updated to 
reflect current standards and requirements to enhance understanding of 
development approaches for these products consistent with the quality 
by design paradigm.
    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 ``Metered Dose 
Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality 
Considerations.'' 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 includes information collection provisions 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 referenced in this guidance that are related 
to the burden for the submission of investigational new drug 
applications are covered under 21 CFR part 312 and have been approved 
under OMB control number 0910-0014. The collections of information 
referenced in this guidance that are related to the burden for the 
submission of new drug applications that are covered under 21 CFR part 
314 have been approved under OMB control number 0910-0001. The 
submission of prescription drug product labeling under 21 CFR 201.56 
and 201.57 is approved under OMB control number 0910-0572.
    The guidance also discusses labeling for MDI and DPI drug products, 
and references 21 CFR part 201. In the Federal Register of December 18, 
2014 (79 FR 75506), FDA published its proposed rule on the electronic 
distribution of prescribing information for human prescription drugs, 
including biological products. In Section VII, ``Paperwork Reduction 
Act of 1995,'' FDA estimated the burden to design, test, and produce 
the label for a drug product's immediate container and outer container 
or package, as set forth in 21 CFR part 201, including Sec. Sec.  
201.10, 201.100(b), and other sections in subpart A and subpart B.

III. Electronic Access

    Persons with access to the internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: April 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08200 Filed 4-18-18; 8:45 am]
 BILLING CODE 4164-01-P