[Federal Register Volume 83, Number 188 (Thursday, September 27, 2018)]
[Notices]
[Pages 48822-48824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on a proposed information collection involving 
interviews with entities that submit a Request for Designation (RFD) or 
pre-RFD, an Investigational New Drug (IND) application or pre-IND 
request, or a New Drug Application (NDA) or Biologics License 
Application (BLA) for a combination product to FDA.

DATES: Submit either electronic or written comments on the collection 
of information by November 26, 2018.

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 November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 26, 2018. 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-2018-N-2969 for ``Assessment of Combination Product Review 
Practices.'' 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

[[Page 48823]]

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.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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.

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 (CDRH) 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 
(MDUFMA) 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.
    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:

[[Page 48824]]



                                 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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Pre-test........................               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 1.0 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 1.0 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: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21038 Filed 9-26-18; 8:45 am]
BILLING CODE 4164-01-P