2019-15595. Final Guidance for Industry and FDA Staff on Postmarketing Safety Reporting for Combination Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff.” The guidance describes and explains the final rule on postmarketing safety reporting (PMSR) for combination products, issued on December 20, 2016, and provides recommendations for complying with the PMSR requirements as well as hypothetical scenarios that illustrate how to comply with certain PMSR requirements.

DATES:

The announcement of the guidance is published in the Federal Register on July 23, 2019.

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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 below (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-2008-N-0424 for “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://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 http://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 http://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 a single hard copy of the guidance document entitled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff” to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg 32, Room 5129, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Melissa Burns or 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.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry and FDA staff entitled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff.” The guidance provides general information on combination products; how FDA regulates combination products; a summary of the combination product PMSR final rule (21 CFR part 4, subpart B); an overview of which entities are subject to the final rule and what safety reporting requirements apply to such entities; detailed discussion of specific combination product PMSR report types; guidance on where, how, and when to submit PMSR reports to FDA; and hypothetical scenarios that illustrate how to comply with certain combination product PMSR requirements.

FDA carefully considered the comments received on the draft guidance, and revised the guidance as appropriate in response to the comments. Combination PMSR information, including examples to illustrate how to report combination production information in electronic reporting systems, is also available on FDA's website at https://www.fda.gov/​combination-products/​guidance-regulatory-information/​postmarketing-safety-reporting-combination-products. FDA encourages combination product applicants to contact the lead Center for their combination product and/or the Office of Combination Products if they have questions on PMSR compliance.

II. Significance of Guidance

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 Postmarketing Safety Reporting 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.

III. Electronic Access

Persons with access to the internet may obtain the guidance document at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​combination-products-guidance-documents.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. 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 314.80(c) and (e), as well as for 21 CFR 314.81(b) are approved under OMB control numbers 0910-0001, 0910-0230, and 0910-0291. The information collection provisions for 21 CFR 600.80 and 600.81 are approved under OMB control number 0910-0308. Those for 21 CFR 606.170 are approved under OMB control number 0910-0116. Those for 21 CFR 606.171 are approved under OMB control number 0910-0458. The information collection provisions for 21 CFR 803.50, 803.53, and 803.56 are approved under OMB control numbers 0910-0291 and 0910-0437. The information collection provisions for 21 CFR 806.10 and 806.20 are approved under OMB control number 0910-0359. The information collection provisions for 21 CFR 4.102, 4.103, and 4.105 are approved under OMB control number 0910-0834.

Dated: July 17, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.