[Federal Register Volume 85, Number 228 (Wednesday, November 25, 2020)]
[Notices]
[Pages 75338-75339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0380]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Product Jurisdiction 
and Combination Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) 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 (PRA) of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by December 28, 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 collection is 0910-0523. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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.

Product Jurisdiction and Combination Products--21 CFR Part 3

OMB Control Number 0910-0523--Revision

    This information collection supports implementation of section 
503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 353(g)), as amended by the 21st Century Cures Act (Pub. L. 114-
255) (Cures Act), section 563 of the FD&C Act (21 U.S.C 360bbb-2) added 
to the FD&C Act by the Food and Drug Administration Modernization Act 
of 1997 (Pub. L. 105-115), and Agency regulations in 21 CFR part 3. 
Section 503(g) of the FD&C Act expressly provides for the regulation of 
combination products, including how primary Agency responsibility shall 
be designated for such products and how certain submissions regarding 
such products may be made to the Agency. Section 563 of the FD&C Act 
requires FDA to classify products as biological products, devices, 
drugs, or combination products and to assign products to an Agency 
component for regulation, in response to requests for designation 
(RFDs) submitted by product sponsors. We updated our regulations in 21 
CFR part 3 in 2005 to clarify the meaning of the statutory term 
``primary mode of action,'' which determines the FDA component to which 
a combination product is assigned. We proposed to update these 
regulations further on May 15, 2018 (83 FR 22428), intending to: (1) 
Clarify the scope of our regulations; (2) streamline and clarify the 
appeals process; (3) align the regulations with more recent legislative 
and regulatory measures; (4) update advisory content; and (5) clarify 
Agency policies and practices.
    We are revising the information collection to include changes to 
these existing procedures and current statutory and legislative 
mandates. Specifically, as amended by the Cures Act, section 503(g) of 
the FD&C Act includes provisions exclusive to FDA's Office of 
Combination Products (OCP) and/or to provide for combination product-
specific submission types, including provisions addressing engagement 
between OCP and combination product sponsors and Combination Product 
Agreement Meetings (CPAMs) for sponsors to engage with FDA. In 
addition, FDA has developed an associated jurisdictional process to the 
RFD process, the pre-RFD process, for sponsors to obtain feedback 
regarding medical product classification and assignment.
    To assist respondents with format and content elements related to 
the information collection for RFDs and pre-RFDs, we have developed 
proposed Forms FDA 5003, 5004, and 5005 (pre-request and request for 
designation). To support RFD and pre-RFD submissions, FDA has also made 
information technology improvements, enabling sponsors to use preferred 
submission methods, including automated, electronic, mechanical, and 
other technological collection techniques. We expect the use of 
improved technology to enhance sponsors' user experience with 
submissions.
    We have also developed Agency guidance consistent with sections 
503(g) and 563 of the FD&C Act and with our Good Guidance Practice 
regulations in 21 CFR 10.115 (approved under OMB control number 0910-
0191).
    The guidance entitled ``How to Write a Request for Designation'' 
(issued April 2011), provides instruction regarding the information 
that needs to be submitted to OCP in a RFD as described in 21 CFR 3.7. 
The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-write-request-designation-rfd. In the Federal Register of July 17, 2019 (84 FR 
34188), we published a notice requesting public comment on the proposed 
collection of information associated with 21 CFR part 3; no comments 
were received.
    The guidance entitled ``How to Prepare a Pre-Request for 
Designation,'' was developed to assist sponsors in obtaining a 
preliminary, nonbinding assessment from OCP through the pre-RFD 
process. The guidance explains the pre-RFD process and helps a sponsor 
understand the type of information to provide in a pre-RFD submission. 
The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/how-prepare-pre-request-designation-pre-rfd. In the Federal Register of January 13, 2017 (82 FR 
4351), we published a notice announcing the availability of the draft 
guidance that included an analysis under the PRA and solicited public 
comment on the recommended information collection. In consideration of 
comments, we made minor edits to the guidance, including clarifying our 
pledge of confidentiality for information submitted and clarifying that 
OCP may be contacted at any time to discuss questions. No comments 
suggested revision to the information collection, and therefore we made 
no adjustment in our burden estimate.
    The guidance entitled ``Requesting FDA Feedback on Combination 
Products,'' was developed to discuss ways in which combination product 
sponsors can obtain feedback from FDA on scientific and regulatory 
questions

[[Page 75339]]

and to describe best practices for FDA and sponsors when interacting on 
these topics. The guidance is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requesting-fda-feedback-combination-products. In the Federal Register of December 26, 
2019 (84 FR 70976), we published a notice announcing the availability 
of the draft guidance that included an analysis under the PRA and 
solicited public comment on the proposed collection of information for 
CPAMs. One comment was received in support of the collection but 
suggested no change in FDA's burden estimate.
    Respondents to the information collection are sponsors of medical 
products, including combination products. We estimate the burden of 
this collection of information as follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of                    Average burden
    21 CFR section; activity         Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
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3.7; request for designation....              53               1              53              24           1,272
Pre-RFD submissions.............              83               1              83              24           1,992
CPAMs requests..................               3               1               3              25              75
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    Total.......................  ..............  ..............  ..............  ..............            3339
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    For RFDs and pre-RFDs, our estimate is based on the number of 
submissions received from October 1, 2018, to September 30, 2019. We 
assume 1 submission per respondent, for an annual average of 53 RFD 
submissions, and 83 pre-RFD submissions and assume that each submission 
requires an average of 24 hours to prepare and submit to FDA.
    Our estimate for CPAM requests is based on future activity in light 
of the minimal use of CPAMs to date; FDA has received two CPAM requests 
since the enactment of the Cures Act in December 2016. We estimate one 
CPAM request will be received per year by each medical product center 
(Center for Biologics Evaluation and Research, Center for Drug 
Evaluation and Research, and Center for Devices and Radiological 
Health). We assume it will take sponsors approximately 25 hours to 
compile and submit the recommended information. Because we expect 
burden associated with application submissions is already captured by 
approved information collection requests for drug, biologic, and 
medical device applications, respectively (approved under OMB control 
numbers 0910-0001, 0910-0338, and 0910-0231), we do not include burden 
associated with application submissions captured by these programs in 
this information collection request.

    Dated: November 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26062 Filed 11-24-20; 8:45 am]
BILLING CODE 4164-01-P