[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35399-35400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15595]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0424]


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

[[Page 35400]]

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.
[FR Doc. 2019-15595 Filed 7-22-19; 8:45 am]
 BILLING CODE 4164-01-P