Agency Information Collection Activities; Proposed Collection; Comment Request; Assessment of Combination Product Review Practices, 48822-48824 [2018-21038]
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
Third-Party Disclosure Burden
Under § 54.4(b), clinical investigators
supply to the sponsor of a covered study
financial information sufficient to allow
the sponsor to submit complete and
accurate certification or disclosure
statements. Clinical investigators are
accustomed to supplying such
information when applying for research
grants. Also, most people know the
financial holdings of their immediate
family and records of such interests are
generally accessible because they are
needed for preparing tax records. For
these reasons, FDA estimates that the
time required for this task may range
from 5 to 15 minutes; we used the mean,
10 minutes, for the average burden per
disclosure. The number of respondents
is the sum of the number of affected
applications multiplied by the mean
(rounded) of the estimated number of
investigators for each application type
(see table 1).
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
54.4(b)—Clinical Investigators ..........
1 There
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section
7,894
Total annual
disclosures
1
7,894
Average burden per disclosure
0.17 (10 minutes) .............................
Total hours 2
1,342
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Our estimated burden for the
information collection reflects an
overall increase of 222 hours and a
corresponding increase of 893
responses/records. We attribute this
adjustment to an increase in the number
of affected applications and the number
of investigators. No program changes
were made.
Dated: September 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21039 Filed 9–26–18; 8:45 am]
BILLING CODE 4164–01–P
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.
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 preRFD, an Investigational New Drug (IND)
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SUMMARY:
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application or pre-IND request, or a New
Drug Application (NDA) or Biologics
License Application (BLA) for a
combination product to FDA.
Submit either electronic or
written comments on the collection of
information by November 26, 2018.
DATES:
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.
ADDRESSES:
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.
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• 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
E:\FR\FM\27SEN1.SGM
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Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
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/201523389.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, PRAStaff@
fda.hhs.gov.
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
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:20 Sep 26, 2018
Jkt 244001
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
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48823
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/preINDs 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/preRFD 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:
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48824
Federal Register / Vol. 83, No. 188 / Thursday, September 27, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Total annual
responses
Average
burden per
response
Total hours 1
Pre-test .................................................................................
Interviews .............................................................................
5
339
1
1
5
339
1.5
1.5
7.5
508.5
Total ..............................................................................
........................
........................
........................
........................
516
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0180]
Coronary Drug-Eluting Stents—
Nonclinical and Clinical Studies and
Companion Guidance Document; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
notice of availability, published in the
Federal Register of March 27, 2008. In
that document, FDA requested
comments on two draft guidance
documents entitled ‘‘Coronary DrugEluting Stents—Nonclinical and
Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and
Clinical Studies Draft Companion
Guidance Document.’’ The Agency is
reopening the comment period to allow
interested persons to provide updated
comments and any new information.
SUMMARY:
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Number of
responses per
respondent
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FDA is reopening the comment
period on the notice of availability
published March 27, 2008 (73 FR
16311). Submit either electronic or
written comments on the draft
guidances by December 26, 2018, to
ensure that the Agency considers your
comment on the draft guidances before
it begins work on the final version of the
guidances.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2008–D–0180 for ‘‘Coronary DrugEluting Stents—Nonclinical and
Clinical Studies’’ and ‘‘Coronary DrugEluting Stents—Nonclinical and
Clinical Studies Draft Companion
Guidance Document.’’ Received
comments 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\27SEN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
Portion of study Number of responses per Total annual Average burden Total hours
respondents respondent responses per response \1\
----------------------------------------------------------------------------------------------------------------
Pre-test........................ 5 1 5 1.5 7.5
Interviews...................... 339 1 339 1.5 508.5
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 516
----------------------------------------------------------------------------------------------------------------
\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
