Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions, 61493-61494 [2010-25010]
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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
their intended audiences. Testing
messages with a sample of the target
audience will allow FDA to refine
messages while still in the
developmental stage. Respondents will
be asked to give their reaction to the
messages in either individual or group
settings.
Third, as evaluative research, it will
allow FDA to ascertain the effectiveness
of the messages and the distribution
method of these messages in achieving
the objectives of the message campaign.
Evaluation of campaigns is a vital link
61493
in continuous improvement of
communications at FDA.
FDA estimates the burden of this
collection of information based on
recent prior experience with the various
types of data collection methods
described above:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
21 CFR 1003(d)(2)(D)
16,448
1
16,448
0.1739
2,860
Total
16,448
1
16,448
0.1739
2,860
1 There
are no capital costs associated with this collection of information.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–25011 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0468]
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
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
FDA’s patent term restoration
regulations on due diligence petitions
for regulatory review period revision.
Where a patented product must receive
FDA approval before marketing is
permitted, the Office of Patents and
Trademarks may add a portion of the
FDA review time to the term of a patent.
Petitioners may request reductions in
the regulatory review time if FDA
marketing approval was not pursued
with ‘‘due diligence.’’
mstockstill on DSKH9S0YB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
Submit either electronic or
written comments on the collection of
information by December 6, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
P150–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@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
DATES:
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
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 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 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 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 (PTO) to extend the
patent term by a portion of the time
during which FDA’s safety and
E:\FR\FM\05OCN1.SGM
05OCN1
61494
Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices
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 PTO based on a
statutory formula. When a patent holder
submits an application for patent term
extension to PTO, PTO requests
information from FDA, including the
length of the regulatory review period
for the patented product. If PTO
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 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 is 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, 12 requests for revision of
the regulatory review period have been
submitted under § 60.24. For 2007,
2008, and 2009, a total of three, or one
per year, have been submitted under
§ 60.24. Two regulatory review periods
have been altered. During that same
time period, two due diligence petitions
were submitted to FDA under § 60.30,
for an average of fewer than one per
year. There have been no requests for
hearings under § 60.40 regarding the
decisions on such petitions; 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 REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
60.24(a)
1
100
1
100
100
60.30
1
50
1
50
50
60.40
1
100
1
10
10
Total
160
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–25010 Filed 10–4–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSKH9S0YB1PROD with NOTICES
[Docket No. FDA–2010–N–0492]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices:
Recommended Glossary and
Educational Outreach to Support Use
of Symbols on Labels and in Labeling
of In Vitro Diagnostic Devices Intended
for Professional Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
VerDate Mar<15>2010
18:36 Oct 04, 2010
Jkt 223001
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 reporting requirements for the
collection ‘‘Recommended Glossary and
Educational Outreach to Support Use of
Symbols on Labels and in Labeling of In
Vitro Diagnostic Devices Intended for
Professional Use.’’
Submit written or electronic
comments on the collection of
information by December 6, 2010.
DATES:
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
ADDRESSES:
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@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,
including each proposed extension of an
SUPPLEMENTARY INFORMATION:
E:\FR\FM\05OCN1.SGM
05OCN1
]]>Agencies
[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61493-61494]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-25010]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0468]
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 FDA's patent term restoration
regulations on due diligence petitions for regulatory review period
revision. Where a patented product must receive FDA approval before
marketing is permitted, the Office of Patents and Trademarks may add a
portion of the FDA review time to the term of a patent. Petitioners may
request reductions in the regulatory review time if FDA marketing
approval was not pursued with ``due diligence.''
DATES: Submit either electronic or written comments on the collection
of information by December 6, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
P150-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@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 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
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 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
(PTO) to extend the patent term by a portion of the time during which
FDA's safety and
[[Page 61494]]
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 PTO based on a statutory formula. When a patent
holder submits an application for patent term extension to PTO, PTO
requests information from FDA, including the length of the regulatory
review period for the patented product. If PTO 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 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 is 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, 12 requests for revision of the regulatory review
period have been submitted under Sec. 60.24. For 2007, 2008, and 2009,
a total of three, or one per year, have been submitted under Sec.
60.24. Two regulatory review periods have been altered. During that
same time period, two due diligence petitions were submitted to FDA
under Sec. 60.30, for an average of fewer than one per year. There
have been no requests for hearings under Sec. 60.40 regarding the
decisions on such petitions; 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 Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual Hours per
Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
60.24(a) 1 100 1 100 100
----------------------------------------------------------------------------------------------------------------
60.30 1 50 1 50 50
----------------------------------------------------------------------------------------------------------------
60.40 1 100 1 10 10
----------------------------------------------------------------------------------------------------------------
Total 160
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: September 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-25010 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S
