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Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Availability

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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations.”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Submit either electronic or written comments on the draft guidance by June 18, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.

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FOR FURTHER INFORMATION CONTACT:

Richard Lostritto, Center for Drug Start Printed Page 17421Evaluation and Research, (HFD-860), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993, 301-796-1697.

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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 §§ 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.

Start Signature

Dated: April 13, 2018.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2018-08200 Filed 4-18-18; 8:45 am]

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