[Federal Register Volume 85, Number 84 (Thursday, April 30, 2020)]
[Notices]
[Pages 23971-23973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09175]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Postmarketing Safety Information Sharing by 
Constituent Part Applicants for Combination Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the requirements under the Postmarketing 
Safety Reporting Rule for Combination Product for Constituent Part 
Applicants to share specified adverse event information with one 
another.

DATES: Submit either electronic or written comments on the collection 
of information by June 29, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 29, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 29, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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 ``Postmarketing Safety Information Sharing by 
Constituent Part Applicants for Combination Products.'' Received 
comments, those filed in a timely manner (see ADDRESSES), 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

[[Page 23972]]

    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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Information Sharing Among Constituent Part Applicants--21 CFR 4.103

OMB Control Number 0910-0834--Extension

    This information collection request applies to ``constituent part 
applicants'' as defined under 21 CFR 4.101 (i.e., any person holding an 
application under which a constituent part (drug, device, or biological 
product) of a combination product received marketing authorization if 
the other constituent part(s) received marketing authorization under an 
application held by a different person). Under this collection, 
constituent part applicants must share safety information they receive 
related to certain events with the other constituent part applicant(s) 
and maintain associated records.\1\
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    \1\ The Postmarketing Safety Reporting (PMSR) information 
collections for drugs, biological products, and devices found in 
Sec. Sec.  314.80, 314.81, 600.80, 600.81, 606.170, 606.171, 803.50, 
803.53, 803.56, 806.10, and 806.20 (21 CFR 314.80, 314.81, 600.80, 
600.81, 606.170, 606.171, 803.50, 803.53, 803.56, 806.10, and 
806.20) have already been approved and are in effect or their 
extension is being sought separately as required, including with 
respect to burden for combination products (reflected in the 
authorization for OMB control number 0910-0834, but, therefore, not 
addressed in this extension request). The pertinent PMSR information 
collection provisions for Sec.  314.80(c) and (e), as well as for 
Sec.  314.81(b) are approved under OMB control numbers 0910-0001, 
0910-0230, and 0910-0291. The information collection provisions for 
Sec. Sec.  600.80 and 600.81 are approved under OMB control number 
0910-0308. Those for Sec.  606.170 are approved under OMB control 
number 0910-0116. Those for Sec.  606.171 are approved under OMB 
control number 0910-0458. The information collection provisions for 
Sec. Sec.  803.50, 803.53, and 803.56 are approved under OMB control 
numbers 0910-0291 and 0910-0437. The information collection 
provisions for Sec. Sec.  806.10 and 806.20 are approved under OMB 
control number 0910-0359.
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    FDA estimates the burden of this collection of information as 
follows:

                                        Table 1--Estimated Annual Third-Party Disclosure and Recordkeeping Burden
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                                                                    Number of
                                                    Number of     disclosures/    Total annual
            21 CFR section/activity               respondents/     records per    disclosures/        Average burden per disclosure/        Total hours
                                                  recordkeepers    respondent/       records                  recordkeeping
                                                                  recordkeeper
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4.103, Sharing information with other                        33              18             594  0.35 (21 minutes)......................             208
 constituent part applicants.
4.103(b) and 4.105(a)(2), Records of                         33              18             594  0.1 (6 minutes)........................              59
 information shared by constituent part
 applicants.
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    Total......................................  ..............  ..............  ..............  .......................................             267
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[[Page 23973]]

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate. We note in this regard that FDA extended the compliance date 
for 21 CFR part 4, subpart B, until July 2020 for most combination 
products, and until January 2021 for the remainder, in response to 
stakeholder feedback, to ensure that Combination Product Applicants 
have sufficient time to update reporting and recordkeeping systems and 
procedures.\2\ Consequently, entities subject to this rule have not yet 
had to comply with this information request.
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    \2\ See Compliance Policy for Combination Product Postmarketing 
Safety Reporting (April 2019) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compliance-policy-combination-product-postmarketing-safety-reporting).

    Dated: April 23, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-09175 Filed 4-29-20; 8:45 am]
BILLING CODE 4164-01-P