Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions, 75824-75826 [2016-26322]
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Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Notices
Applications and Enforcement) 101
Market Street, San Francisco, California
94105–1579:
2. AltaPacific Bancorp, Santa Rosa,
California; to acquire Commerce Bank of
Temecula Valley, Murrieta, California.
Board of Governors of the Federal Reserve
System, October 27, 2016.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2016–26361 Filed 10–31–16; 8:45 am]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Community Services Block
Grant (CSBG) Annual Report.
OMB No.: New.
Description: Section 678E of the
Community Services Block Grant
(CSBG) Act requires States, including
the District of Columbia and the
Commonwealth of Puerto Rico, and U.S.
territories, to annually prepare and
submit a report on the measured
performance of the State and the eligible
entities in the State. Prior to the
participation of the State in the
performance measurement system, the
State shall include in the report any
information collected by the State
relating to such performance. Each State
shall also include in the report an
accounting of the expenditure of funds
received by the State through the CSBG
program, including an accounting of
funds spent on administrative costs by
the State and the eligible entities, and
funds spent by the eligible entities on
the direct delivery of local services, and
shall include information on the
number of and characteristics of clients
served under the subtitle in the State,
based on data collected from the eligible
entities. The State shall also include in
the report a summary describing the
training and technical assistance offered
by the State.
This request will support an
automated Annual Report form,
streamlining State administrative
information and incorporating Results
Oriented Management and
Accountability (ROMA) Next
Generation as well as National
Performance Indicators (NPI) for
individual, family, and community
measures as reported by eligible entities.
The revised and automated form may
impose an added first-use burden;
however, this burden will lessen in
subsequent years. Copies of the
proposed collection of information can
be obtained by visiting: https://
www.acf.hhs.gov/programs/ocs/
programs/csbg.
Respondents: State Governments,
including the District of Columbia and
the Commonwealth of Puerto Rico, and
U.S. territories and CSBG eligible
entities.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
asabaliauskas on DSK3SPTVN1PROD with NOTICES
CSBG Annual Report ......................................................................................
CSBG Annual Report ......................................................................................
Estimated Total Annual Burden
Hours: 793,026.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
VerDate Sep<11>2014
00:01 Nov 01, 2016
Jkt 241001
52
1035
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–26336 Filed 10–31–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1393]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Patent Term
Restoration, Due Diligence Petitions,
Filing, Format, and Content of
Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
SUMMARY:
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden hours
per response
203
756
Total burden
hours
10,566
782,460
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
Patent Term Restoration, Due Diligence
Petitions, Filing, Format, and Content of
Petitions.
DATES: Submit either electronic or
written comments on the collection of
information by January 3, 2017.
ADDRESSES: You may submit comments
as follows:
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
E:\FR\FM\01NON1.SGM
01NON1
Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2013–N–1393 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Patent
Term Restoration, Due Diligence
Petitions, Filing, Format, and Content of
Petitions.’’ 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
Division of Dockets Management
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 Division of Dockets
VerDate Sep<11>2014
00:01 Nov 01, 2016
Jkt 241001
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 11601 Landsdown Street,
10A63, North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
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,
including each proposed extension of an
existing 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
PO 00000
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Fmt 4703
Sfmt 4703
75825
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.
Patent Term Restoration, Due Diligence
Petitions, Filing, Format, and Content of
Petitions—21 CFR Part 60—OMB
Control Number 0910–0233—Extension
FDA’s patent extension activities are
conducted under the authority of the
Drug Price Competition and Patent
Term Restoration Act of 1984 (21 U.S.C.
355(j)) and the Generic Animal Drug
and Patent Term Restoration Act of 1988
(35 U.S.C. 156). New human drug,
animal drug, human biological, medical
device, food additive, or color additive
products regulated by the FDA must
undergo FDA safety, or safety and
effectiveness review before marketing is
permitted. Where the product is covered
by a patent, part of the patent’s term
may be consumed during this review,
which diminishes the value of the
patent. In enacting the Drug Price
Competition and Patent Term
Restoration Act of 1984 and the Generic
Animal Drug and Patent Term
Restoration Act of 1988, Congress
sought to encourage development of
new, safer, and more effective medical
and food additive products. It did so by
authorizing the U.S. Patent and
Trademark Office (USPTO) to extend
the patent term by a portion of the time
during which FDA’s safety and
effectiveness review prevented
marketing of the product. The length of
the patent term extension is generally
limited to a maximum of 5 years, and
is calculated by USPTO based on a
statutory formula. When a patent holder
submits an application for patent term
extension to USPTO, USPTO requests
information from FDA, including the
length of the regulatory review period
for the patented product. If USPTO
concludes that the product is eligible for
patent term extension, FDA publishes a
notice that describes the length of the
regulatory review period and the dates
used to calculate that period. Interested
parties may request, under § 60.24 (21
CFR 60.24), revision of the length of the
regulatory review period, or may
petition under § 60.30 (21 CFR 60.30) to
reduce the regulatory review period by
any time where marketing approval was
not pursued with ‘‘due diligence.’’
The statute defines due diligence as
‘‘that degree of attention, continuous
directed effort, and timeliness’’ as may
E:\FR\FM\01NON1.SGM
01NON1
75826
Federal Register / Vol. 81, No. 211 / Tuesday, November 1, 2016 / Notices
reasonably be expected from, and are
ordinarily exercised by, a person during
a regulatory review period. As provided
in § 60.30(c), a due diligence petition
‘‘shall set forth sufficient facts,
including dates if possible, to merit an
investigation by FDA of whether the
applicant acted with due diligence.’’
Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates
whether any change in the regulatory
review period if necessary. If so, the
corrected regulatory review period is
published in the Federal Register. A
due diligence petitioner not satisfied
with FDA’s decision regarding the
petition may, under § 60.40 (21 CFR
60.40), request an informal hearing for
reconsideration of the due diligence
determination. Petitioners are likely to
include persons or organizations having
knowledge that FDA’s marketing
permission for that product was not
actively pursued throughout the
regulatory review period. The
information collection for which an
extension of approval is being sought is
the use of the statutorily created due
diligence petition.
Since 1992, 20 requests for revision of
the regulatory review period have been
submitted under § 60.24(a). For 2013,
2014 and 2015, a total of 5 requests have
been submitted under § 60.24(a). During
that same time period, there have been
no requests under §§ 60.30 and 60.40;
however, for purposes of this
information collection approval, we are
estimating that we may receive one
submission annually.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
60.24(a) ................................................................................
60.30 ....................................................................................
60.40 ....................................................................................
3
1
1
1.66
1
1
5
1
1
100
50
10
500
50
10
Total ..............................................................................
........................
........................
........................
........................
560
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
DATES:
[FR Doc. 2016–26322 Filed 10–31–16; 8:45 am]
ADDRESSES:
BILLING CODE 4164–01–P
as follows:
Submit either electronic or
written comments on the collection of
information by January 3, 2017.
You may submit comments
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1163]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Institutional
Review Boards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the recordkeeping requirements for
institutional review boards (IRBs).
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
00:01 Nov 01, 2016
Jkt 241001
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’’).
PO 00000
Frm 00022
Fmt 4703
Sfmt 4703
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2013–N–1163 for ‘‘Agency Information
Collection Activities: Proposed
Collection; Comment Request;
Institutional Review Boards.’’ 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 Division of Dockets
Management 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
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[Federal Register Volume 81, Number 211 (Tuesday, November 1, 2016)]
[Notices]
[Pages 75824-75826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26322]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1393]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Patent Term Restoration, Due Diligence Petitions,
Filing, Format, and Content of Petitions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on Patent Term Restoration, Due
Diligence Petitions, Filing, Format, and Content of Petitions.
DATES: Submit either electronic or written comments on the collection
of information by January 3, 2017.
ADDRESSES: You may submit comments as follows:
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
[[Page 75825]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2013-N-1393 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Patent Term Restoration, Due
Diligence Petitions, Filing, Format, and Content of Petitions.''
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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 11601 Landsdown
Street, 10A63, North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
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, including
each proposed extension of an existing 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.
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and
Content of Petitions--21 CFR Part 60--OMB Control Number 0910-0233--
Extension
FDA's patent extension activities are conducted under the authority
of the Drug Price Competition and Patent Term Restoration Act of 1984
(21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term
Restoration Act of 1988 (35 U.S.C. 156). New human drug, animal drug,
human biological, medical device, food additive, or color additive
products regulated by the FDA must undergo FDA safety, or safety and
effectiveness review before marketing is permitted. Where the product
is covered by a patent, part of the patent's term may be consumed
during this review, which diminishes the value of the patent. In
enacting the Drug Price Competition and Patent Term Restoration Act of
1984 and the Generic Animal Drug and Patent Term Restoration Act of
1988, Congress sought to encourage development of new, safer, and more
effective medical and food additive products. It did so by authorizing
the U.S. Patent and Trademark Office (USPTO) to extend the patent term
by a portion of the time during which FDA's safety and effectiveness
review prevented marketing of the product. The length of the patent
term extension is generally limited to a maximum of 5 years, and is
calculated by USPTO based on a statutory formula. When a patent holder
submits an application for patent term extension to USPTO, USPTO
requests information from FDA, including the length of the regulatory
review period for the patented product. If USPTO concludes that the
product is eligible for patent term extension, FDA publishes a notice
that describes the length of the regulatory review period and the dates
used to calculate that period. Interested parties may request, under
Sec. 60.24 (21 CFR 60.24), revision of the length of the regulatory
review period, or may petition under Sec. 60.30 (21 CFR 60.30) to
reduce the regulatory review period by any time where marketing
approval was not pursued with ``due diligence.''
The statute defines due diligence as ``that degree of attention,
continuous directed effort, and timeliness'' as may
[[Page 75826]]
reasonably be expected from, and are ordinarily exercised by, a person
during a regulatory review period. As provided in Sec. 60.30(c), a due
diligence petition ``shall set forth sufficient facts, including dates
if possible, to merit an investigation by FDA of whether the applicant
acted with due diligence.'' Upon receipt of a due diligence petition,
FDA reviews the petition and evaluates whether any change in the
regulatory review period if necessary. If so, the corrected regulatory
review period is published in the Federal Register. A due diligence
petitioner not satisfied with FDA's decision regarding the petition
may, under Sec. 60.40 (21 CFR 60.40), request an informal hearing for
reconsideration of the due diligence determination. Petitioners are
likely to include persons or organizations having knowledge that FDA's
marketing permission for that product was not actively pursued
throughout the regulatory review period. The information collection for
which an extension of approval is being sought is the use of the
statutorily created due diligence petition.
Since 1992, 20 requests for revision of the regulatory review
period have been submitted under Sec. 60.24(a). For 2013, 2014 and
2015, a total of 5 requests have been submitted under Sec. 60.24(a).
During that same time period, there have been no requests under
Sec. Sec. 60.30 and 60.40; however, for purposes of this information
collection approval, we are estimating that we may receive one
submission annually.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
60.24(a)........................ 3 1.66 5 100 500
60.30........................... 1 1 1 50 50
60.40........................... 1 1 1 10 10
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Total....................... .............. .............. .............. .............. 560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26322 Filed 10-31-16; 8:45 am]
BILLING CODE 4164-01-P
