Document ID: FDA-2008-N-0424-0038
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products
Posted Date: 2020-08-05T04:00Z

[Federal Register Volume 85, Number 151 (Wednesday, August 5, 2020)]
[Notices]
[Pages 47389-47390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17041]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by September 4, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information

[[Page 47390]]

collection is 0910-0834. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Postmarketing Information Sharing Among Constituent Part Applicants for 
Combination Products--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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    In the Federal Register of April 30, 2020 (85 FR 23971), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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/recordkeeping    Total hours
                                             recordkeepers    respondent/       records
                                                             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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    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: July 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17041 Filed 8-4-20; 8:45 am]
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