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Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability

This document has a comment period that ends in 81 days. (05/07/2019) Submit a formal comment

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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Principles of Premarket Pathways for Combination Products.” This draft guidance presents FDA's current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. FDA is publishing this draft guidance as part of its efforts to implement the 21st Century Cures Act (Cures Act) and in keeping with the Agency's long-standing commitment to transparency, efficiency, and regulatory consistency to facilitate development of safe and effective combination products.

DATES:

Submit either electronic or written comments on the draft guidance by May 7, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-2019-D-0078 for “Principles of Premarket Pathways for Combination Products.” 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)).Start Printed Page 2237

Submit written requests for single copies of the draft guidance to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, 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:

John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930.

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SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Principles of Premarket Pathways for Combination Products.” This draft guidance presents FDA's current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. This draft guidance provides general, high-level information relevant to combination products.

Section 3038 of the Cures Act (Pub. L. 114-255), enacted in December 2016, substantially amended section 503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353(g)), the principal section of the FD&C Act expressly addressing combination products. General themes of these amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by ensuring that Agency components and staff coordinate appropriately on premarket review of these products, and that Agency thinking is aligned in conducting these reviews. This guidance is part of FDA's efforts to implement section 3038 of the Cures Act.

The draft guidance describes premarket pathways available for combination products and related considerations as well as illustrative examples on how these principles can be applied.

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 “Principles of Premarket Pathways for Combination Products.” 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. Other Issues for Consideration

The FD&C Act (section 503(g)(1)(B)) provides that the Secretary of HHS shall conduct the premarket review of any combination product under a single application, whenever appropriate. FDA requests public comment on those circumstances when a single application may not be appropriate, and thus two applications—one to the lead center and one to the non-lead center—should be submitted. In those circumstances, are there steps FDA should take to avoid duplication of effort or duplicate data submission and to minimize unnecessary burden? As described in the draft guidance, FDA's current thinking is that a single application is generally appropriate for a combination product. However, the Agency anticipates that a single application may not be appropriate in limited cases; for example, when the characteristics of the non-lead constituent part give rise to safety and effectiveness or regulatory oversight issues that may be best addressed through separate applications. Such cases may include, for example, when a complex device-led co-packaged or cross-labeled combination product includes a constituent part that is a new molecular entity (NME) that potentially has, or is intended to have, systemic effects. In this case, the NME may need to be reviewed in a separate application. FDA requests public comment on this issue.

III. Electronic Access

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

IV. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of information found in FDA regulations and guidance. These collections of information 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 in 21 CFR part 3 have been approved under OMB control number 0910-0523 and the collections of information in the guidance “How to Prepare a Pre-Request for Designation (Pre-RFD)” have been approved under OMB control number 0910-0845. The collections of information for applications for FDA approval to market a new drug (certain provisions of 21 CFR part 314) have been approved under OMB control number 0910-0001; the collections of information in 21 CFR part 601 have been approved under 0910-0338; and the collections of information in section 351(k) of the Public Health Service Act (42 U.S.C. 262) have been approved under 0910-0719. The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 860 have been approved under OMB control number 0910-0138; the collections of information in the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756; and the collections of information in the guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844.

Start Signature

Dated: January 17, 2019.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2019-01196 Filed 2-5-19; 8:45 am]

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