83 FR 17420 - Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 76 (April 19, 2018)

Page Range		17420-17421
FR Document		2018-08200

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations.''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.

Federal Register, Volume 83 Issue 76 (Thursday, April 19, 2018)

[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Notices]
[Pages 17420-17421]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-08200]

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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Quality Considerations; Draft Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry entitled ``Metered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.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. 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

Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Notices 17421

Evaluation and Research, (HFD–860), have been approved under OMB control Time: 11:00 a.m. to 12:30 p.m.
Food and Drug Administration, 10903 number 0910–0001. The submission of Agenda: To review and evaluate grant
New Hampshire Ave., Bldg. 51, Rm. prescription drug product labeling applications.
Place: National Institutes of Health, 5601
4132, Silver Spring, MD 20993, 301– under 21 CFR 201.56 and 201.57 is
Fishers Lane, Rockville, MD 20892
796–1697. approved under OMB control number (Telephone Conference Call).
SUPPLEMENTARY INFORMATION: 0910–0572. Contact Person: J. Bruce Sundstrom, Ph.D.,
The guidance also discusses labeling Scientific Review Officer Scientific Review
I. Background for MDI and DPI drug products, and Program, Division of Extramural Activities,
FDA is announcing the availability of references 21 CFR part 201. In the Room 3G11A, National Institutes of Health/
a draft guidance for industry entitled Federal Register of December 18, 2014 NIAID, 5601 Fishers Lane, MSC 9823,
‘‘Metered Dose Inhaler (MDI) and Dry (79 FR 75506), FDA published its Bethesda, MD 20892–9823, 240–669–5045,
Powder Inhaler (DPI) Drug Products— proposed rule on the electronic sundstromj@niaid.nih.gov.
Quality Considerations.’’ This guidance distribution of prescribing information (Catalogue of Federal Domestic Assistance
describes points to consider to help for human prescription drugs, including Program Nos. 93.855, Allergy, Immunology,
ensure product quality and performance and Transplantation Research; 93.856,
biological products. In Section VII, Microbiology and Infectious Diseases
for MDIs and DPIs. It describes ‘‘Paperwork Reduction Act of 1995,’’ Research, National Institutes of Health, HHS)
chemistry, manufacturing, and controls FDA estimated the burden to design,
information recommended for inclusion test, and produce the label for a drug Dated: April 13, 2018.
in new drug applications (NDAs) and product’s immediate container and Natasha M. Copeland,
abbreviated new drug applications outer container or package, as set forth Program Analyst, Office of Federal Advisory
(ANDAs); however, the principles are in 21 CFR part 201, including §§ 201.10, Committee Policy.
applicable to products used during 201.100(b), and other sections in [FR Doc. 2018–08171 Filed 4–18–18; 8:45 am]
clinical trials and over the product subpart A and subpart B. BILLING CODE 4140–01–P
lifecycle, as well. It also provides
recommendations on certain aspects of III. Electronic Access
labeling for NDA and ANDA MDI and Persons with access to the internet DEPARTMENT OF HEALTH AND
DPI products. FDA previously may obtain the document at either HUMAN SERVICES
published a draft guidance on this topic https://www.fda.gov/Drugs/Guidance
on November 13, 1998. The present ComplianceRegulatoryInformation/ National Institutes of Health
guidance is a revision of the previous Guidances/default.htm or https://
draft, updated to reflect current Center for Scientific Review; Notice of
www.regulations.gov.
standards and requirements to enhance Closed Meeting
Dated: April 13, 2018.
understanding of development Pursuant to section 10(d) of the
Leslie Kux,
approaches for these products Federal Advisory Committee Act, as
consistent with the quality by design Associate Commissioner for Policy.
amended, notice is hereby given of the
paradigm. [FR Doc. 2018–08200 Filed 4–18–18; 8:45 am]
following meeting.
This draft guidance is being issued BILLING CODE 4164–01–P The meeting will be closed to the
consistent with FDA’s good guidance public in accordance with the
practices regulation (21 CFR 10.115). provisions set forth in sections
The draft guidance, when finalized, will DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
represent the current thinking of FDA HUMAN SERVICES as amended. The grant applications and
on ‘‘Metered Dose Inhaler (MDI) and the discussions could disclose
Dry Powder Inhaler (DPI) Drug National Institutes of Health
confidential trade secrets or commercial
Products—Quality Considerations.’’ It National Institute of Allergy and property such as patentable material,
does not establish any rights for any Infectious Diseases; Notice of Closed and personal information concerning
person and is not binding on FDA or the Meeting individuals associated with the grant
public. You can use an alternative applications, the disclosure of which
approach if it satisfies the requirements Pursuant to section 10(d) of the would constitute a clearly unwarranted
of the applicable statutes and Federal Advisory Committee Act, as invasion of personal privacy.
regulations. This guidance is not subject amended, notice is hereby given of the
to Executive Order 12866. following meeting. Name of Committee: Center for Scientific
The meeting will be closed to the Review Special Emphasis Panel; Global
II. Paperwork Reduction Act of 1995 Noncommunicable Diseases and Injury
public in accordance with the Across the Lifespan: Exploratory Research.
This guidance includes information provisions set forth in sections Date: April 25, 2018.
collection provisions that are subject to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Time: 11:00 a.m. to 1:30 p.m.
review by the Office of Management and as amended. The grant applications and Agenda: To review and evaluate grant
Budget (OMB) under the Paperwork the discussions could disclose applications.
Reduction Act of 1995 (44 U.S.C. 3501– confidential trade secrets or commercial Place: National Institutes of Health, 6701
3520). The collections of information property such as patentable material, Rockledge Drive, Bethesda, MD 20892
referenced in this guidance that are and personal information concerning (Telephone Conference Call).
related to the burden for the submission individuals associated with the grant Contact Person: Fungai Chanetsa, MPH,
of investigational new drug applications Ph.D., Scientific Review Officer, Center for
applications, the disclosure of which
daltland on DSKBBV9HB2PROD with NOTICES

Scientific Review, National Institutes of
are covered under 21 CFR part 312 and would constitute a clearly unwarranted Health, 6701 Rockledge Drive, Room 3135,
have been approved under OMB control invasion of personal privacy. MSC 7770 Bethesda, MD 20892, 301–408–
number 0910–0014. The collections of Name of Committee: National Institute of 9436, fungai.chanetsa@nih.hhs.gov.
information referenced in this guidance Allergy and Infectious Diseases Special This notice is being published less than 15
that are related to the burden for the Emphasis Panel; NIAID Clinical Trial days prior to the meeting due to the timing
submission of new drug applications Implementation Grant (R01). limitations imposed by the review and
that are covered under 21 CFR part 314 Date: May 11, 2018. funding cycle.

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Document Created: 2018-04-19 00:40:33
Document Modified: 2018-04-19 00:40:33

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 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.
Contact		Richard Lostritto, Center for Drug Evaluation and Research, (HFD-860), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301- 796-1697.
FR Citation		83 FR 17420

83 FR 17420 - Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 76 (April 19, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration