[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Rules and Regulations]
[Pages 17081-17082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08284]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 4

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


Compliance Policy for Combination Product Postmarketing Safety 
Reporting; Immediately in Effect Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of an update to the immediately in effect guidance for 
industry entitled ``Compliance Policy for Combination Product 
Postmarketing Safety Reporting.'' This guidance describes FDA's 
compliance policy for combination product applicants and constituent 
part applicants and activities under FDA regulations that addresses 
combination product postmarketing safety reporting. FDA is updating 
this guidance by extending the period of time during which FDA does not 
intend to enforce certain combination product postmarketing safety 
reporting requirements.

DATES: The announcement of the updated guidance is published in the 
Federal Register on April 24, 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: 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-2008-N-0424 for ``Compliance Policy for Combination Product 
Postmarketing Safety Reporting.'' 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 guidance to the 
Office of Combination Products, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination 
Products, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-5616, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing an update to the immediately in effect guidance 
for industry entitled ``Compliance Policy for Combination Product 
Postmarketing Safety Reporting.'' This guidance was originally issued 
on March 21, 2018 (83 FR 12259). This guidance describes FDA's 
compliance policy for combination product applicants and constituent 
part applicants and activities under 21 CFR part 4, subpart B, which 
was published in the Federal Register of December 20, 2016 (81 FR 
92603) and addresses postmarketing safety reporting for combination 
products. FDA is updating this guidance by extending the period of time 
during which FDA does not intend to enforce certain combination product 
postmarketing safety reporting requirements.
    We are updating this guidance consistent with our good guidance 
practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). We are 
implementing this updated guidance without prior public comment because 
we have determined that prior public participation is not feasible or 
appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec.  10.115(g)(2)). We 
made this determination because FDA needs to communicate its compliance

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policy in a timely manner given the compliance deadlines for certain 
provisions in 21 CFR part 4, subpart B, and the amount of time needed 
for firms to prepare for them. Although this guidance is immediately 
effective, it remains subject to comment in accordance with FDA's GGP 
regulation.
    This guidance represents the current thinking of FDA on this topic. 
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 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.

III. Electronic Access

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

    Dated: April 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08284 Filed 4-23-19; 8:45 am]
 BILLING CODE 4164-01-P