Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Assessment of Combination Product Review Practices, 3459-3460 [2019-01979]
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Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
‘‘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:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product EUCRISA
(crisaborole). EUCRISA indicated for
topical treatment of mild to moderate
atopic dermatitis in patients 2 years of
age and older. Subsequent to this
approval, the USPTO received patent
term restoration applications for
EUCRISA (U.S. Patent Nos. 8,039,451
and 8,168,614) from Anacor
Pharmaceuticals, Inc., and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
November 6, 2017, FDA advised the
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18:30 Feb 11, 2019
Jkt 247001
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
EUCRISA represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
EUCRISA is 3,121 days. Of this time,
2,778 days occurred during the testing
phase of the regulatory review period,
while 343 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: May 31, 2008.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
May 31, 2008.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: January 7, 2016.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
EUCRISA (NDA 207695) was initially
submitted on January 7, 2016.
3. The date the application was
approved: December 14, 2016. FDA has
verified the applicant’s claim that NDA
207695 was approved on December 14,
2016.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 328 days or 1,114
days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
PO 00000
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3459
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01956 Filed 2–11–19; 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; Submission for Office of
Management and Budget Review;
Comment Request; Assessment of
Combination Product Review Practices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\12FEN1.SGM
12FEN1
3460
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
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/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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Portion of study
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours 1
Pretest ..................................................................................
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 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.
VerDate Sep<11>2014
18:30 Feb 11, 2019
Jkt 247001
Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01979 Filed 2–11–19; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2018–N–4735]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Safety Labeling
Changes—Implementation of Section
505(o)(4) of the Federal Food, Drug,
and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Frm 00050
Fmt 4703
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E:\FR\FM\12FEN1.SGM
Notice.
12FEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Number of
Portion of study Number of responses per Total annual Average burden Total hours
respondents respondent responses per response \1\
----------------------------------------------------------------------------------------------------------------
Pretest......................... 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 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
