
[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3459-3460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01979]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2969]


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

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: Fax written comments on the collection of information by March 
14, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Assessment of Combination Product Review Practices.'' 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

[[Page 3460]]

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.

Assessment of Combination Product Review Practices

OMB Control Number 0910-NEW

    In 1991, FDA's Center for Biologics Evaluation and Research (CBER), 
Center for Drug Evaluation and Research (CDER), and Center for Devices 
and Radiological Health entered into ``Intercenter Agreements'' to 
provide guidance on the classification and assignment of medical 
products and to clarify jurisdiction over combination product reviews. 
With the enactment of the Medical Device User Fee and Modernization Act 
of 2002, FDA aimed to achieve prompt assignment of combination 
products, timely and effective premarket reviews, and consistent and 
appropriate postmarket regulation through the establishment of the 
Office of Combination Products (OCP). Since then, OCP has operated to 
further standardize combination product guidance to FDA and industry 
and facilitate coordination between FDA's medical product review 
Centers. As part of the 2017 reauthorization of the Prescription Drug 
User Fee Act (PDUFA), FDA committed to advance the development of drug-
device and biologic-device combination products regulated by CDER and 
CBER through modernization of the combination product review program. 
To that end, FDA committed to contracting with an independent third 
party to assess current practices for combination drug product review, 
to include interviews with combination product sponsors and applicants. 
The contractor for the assessment of combination drug product review 
practices is Eastern Research Group, Inc. (ERG).
    Therefore, in accordance with the PDUFA VI Commitment Letter, FDA 
proposes to have ERG conduct independent interviews of combination 
product sponsors and applicants during the data collection period as 
follows:
     Sponsors with a Request For Designation (RFD) or pre-RFD 
submitted during the data collection period.
     Sponsors with a combination product Investigational New 
Drug (IND) or pre-IND submitted during the data collection period.
     Applicants with a combination product New Drug Application 
(NDA) or Biologics License Application (BLA) that receives a first-
cycle action from FDA during the data collection period.
    The purpose of these interviews is to collect voluntary feedback 
from combination product sponsors and applicants on their experience 
with FDA during the development and review of their products, including 
any challenges or best practices. ERG will anonymize and aggregate 
sponsor/applicant responses prior to inclusion in the assessment. ERG 
will use interview responses to complement and supplement data on 
combination product review parameters obtained through other means, 
such as extraction of data from FDA corporate databases and interviews 
with FDA review staff. FDA will publish ERG's assessment (with 
interview results and findings) on the Agency's public website and a 
link to the assessment in the Federal Register for public comment.
    In the Federal Register of September 27, 2018 (83 FR 48822), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Sponsors submit approximately 150 to 180 RFDs/pre-RFDs and 200 to 
240 combination product original INDs/pre-INDs per year. ERG will 
interview 1 to 3 sponsor representatives at a time for up to 35 RFDs/
pre-RFDs and 48 INDs received by FDA--up to 105 RFD/pre-RFD and 144 
IND/pre-IND sponsor representatives per year. FDA typically reviews 
approximately 25 to 30 combination product original NDAs and original 
BLAs per year. ERG will interview 1 to 3 applicant representatives at a 
time for each application that receives a first-cycle action from FDA--
up to 90 representatives per year. Thus, FDA estimates the burden of 
this collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
        Portion of study             Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response         \1\
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Pretest.........................               5               1               5             1.5             7.5
Interviews......................             339               1             339             1.5           508.5
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    Total.......................  ..............  ..............  ..............  ..............             516
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    ERG will conduct a pretest of the interview protocol with five 
respondents. FDA estimates that it will take 1 to 1.5 hours to complete 
the pretest, for a total of a maximum of 7.5 hours. FDA estimates that 
up to 339 respondents will take part in the interviews each year, with 
each interview lasting 1 to 1.5 hours, for a total of a maximum of 
508.5 hours. Thus, the total estimated annual burden is 516 hours. 
FDA's burden estimate is based on prior experience with similar 
interviews with the regulated community.

    Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01979 Filed 2-11-19; 8:45 am]
 BILLING CODE 4164-01-P


