Agency Information Collection Activities; Proposed Collection; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions, 68454-68455 [2013-27226]
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Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
111.75(a)(1)(ii) sets forth the
information a manufacturer is required
to submit in such a petition. The
regulation also contains a requirement
to ensure that the manufacturer keeps
our response to a petition submitted
under § 111.75(a)(1)(ii) as a record
under § 111.95. The collection of
information in § 111.95 has been
approved under OMB Control No. 0910–
0606.
Description of Respondents: The
respondents to this collection of
information are firms in the dietary
supplement industry, including dietary
supplement manufacturers, packagers
and re-packagers, holders, labelers and
re-labelers, distributors, warehouses,
exporters, importers, large businesses,
and small businesses.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section; CGMP requirements for dietary
supplements
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
111.75(a)(1)(ii) .....................................................................
1
1
1
8
8
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In the last 3 years, we have not
received any new petitions to request an
exemption from 100 percent identity
testing of dietary ingredients; therefore,
the Agency estimates that one or fewer
petitions will be submitted annually.
Based on our experience with petition
processes, we estimate it will take a
requestor about 8 hours to prepare the
factual and legal information necessary
to support a petition for exemption and
to prepare the petition. Although we
have not received any new petitions to
request an exemption from 100 percent
identity testing of dietary ingredients in
the last 3 years, we believe that OMB
approval of these information collection
provisions should be extended to
provide for the potential future need of
a firm in the dietary supplement
industry to petition for an exemption
from 100 percent identity testing of
dietary ingredients.
Dated: November 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27222 Filed 11–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
TKELleY on DSK3SPTVN1PROD with NOTICES
[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
SUMMARY:
VerDate Mar<15>2010
19:20 Nov 13, 2013
Jkt 232001
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 January 13, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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
E:\FR\FM\14NON1.SGM
14NON1
68455
Federal Register / Vol. 78, No. 220 / Thursday, November 14, 2013 / Notices
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 (PTO) 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 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, 15 requests for revision of
the regulatory review period have been
submitted under § 60.24(a). For 2010,
2011, and 2012, a total of three 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
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
60.24(a) ................................................................................
60.30 ....................................................................................
60.40 ....................................................................................
1
1
1
1
1
1
1
1
1
100
50
10
100
50
10
Total ..............................................................................
........................
........................
........................
........................
160
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–27226 Filed 11–13–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2000–N–0110]
Bruce I. Diamond; Denial of Hearing;
Final Debarment Order
TKELleY on DSK3SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is denying Dr.
Bruce I. Diamond’s request for a hearing
and is issuing an order under the
Federal Food, Drug, and Cosmetic Act
SUMMARY:
VerDate Mar<15>2010
19:20 Nov 13, 2013
Jkt 232001
(the FD&C Act) debarring Dr. Diamond
for 10 years from providing services in
any capacity to a person who has an
approved or pending drug product
application. FDA bases this order on
findings that Dr. Diamond was
convicted of felonies under State law for
conduct relating to the development or
approval of a drug product or otherwise
relating to the regulation of a drug
product under the FD&C Act, was
convicted of felonies involving fraud,
and was a material participant in acts
forming the basis of a conviction that
subjects another person to debarment. In
determining the appropriateness and
length of Dr. Diamond’s debarment
period, FDA has evaluated the relevant
considerations listed in the FD&C Act.
Dr. Diamond has failed to file with the
Agency information and analysis
sufficient to create a basis for a hearing
concerning this action.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
This order is effective November
14, 2013.
ADDRESSES: Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: G.
Matthew Warren, Office of Scientific
Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–4613.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
On December 16, 1997, Dr. Diamond
pled guilty to 53 State criminal offenses,
including felonies, in the Superior Court
for the County of Richmond, Georgia,
and the court subsequently entered
judgment against him. The offenses in
the Official Code of Georgia to which
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 78, Number 220 (Thursday, November 14, 2013)]
[Notices]
[Pages 68454-68455]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27226]
-----------------------------------------------------------------------
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 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 January 13, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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
[[Page 68455]]
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 (PTO) 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 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, 15 requests for revision of the regulatory review
period have been submitted under Sec. 60.24(a). For 2010, 2011, and
2012, a total of three 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 information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
60.24(a)........................ 1 1 1 100 100
60.30........................... 1 1 1 50 50
60.40........................... 1 1 1 10 10
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 160
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: November 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27226 Filed 11-13-13; 8:45 am]
BILLING CODE 4160-01-P
