Proposed Information Collection Activity; Comment Request, 17925-17926 [2010-7984]
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17925
Federal Register / Vol. 75, No. 67 / Thursday, April 8, 2010 / Notices
contain patent information described
under § 314.53.
Section 314.53 requires that an
applicant submitting an NDA, an
amendment, or a supplement, except as
provided in § 314.53(d)(2), submit on
Forms 3542 and 3542a, the required
patent information described in this
section.
Compliance with the information
collection burdens under §§ 314.50(h)
and 314.53 consists of submitting with
an NDA, an amendment, or a
supplement (collectively referred to as
‘‘application’’) the required patent
declaration(s) on Form 3542a for each
‘‘patent that claims the drug or a method
of using the drug that is the subject of
the new drug application or amendment
or supplement to it and with respect to
which a claim of patent infringement
could reasonably be asserted if a person
not licensed by the owner of the patent
engaged in the manufacture, use, or sale
of the drug product’’ (§ 314.53(b)). Such
patents claim the drug substance (active
ingredient), drug product (formulation
and composition), or method of use. If
a patent is issued after the application
is filed with FDA but before the
application is approved, the applicant
must submit the required patent
information on Form 3542a as an
amendment to the application, within
30 days of the date of issuance of the
patent.
Within 30 days after the date of
approval of an application, the
applicant must submit Form 3542 for
each patent that claims the drug
substance (active ingredient), drug
product (formulation and composition),
or approved method of use for listing in
the Orange Book. In addition, for
patents issued after the date of approval
of an application, Form 3542 must be
submitted within 30 days of the date of
issuance of the patent.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section § 314.50 (citing
§ 314.53)
No. of
Respondents
No. of Responses per
Respondent
Total Annual
Responses
Hours per
Response
Total Hours
Form FDA 3542a
233
2.6
606
20
12,120
Form FDA 3542
154
2.6
400
5
2,000
Total Reporting Burden Hours:
sroberts on DSKD5P82C1PROD with NOTICES
1 There
14,120
are no operating and maintenance costs or capital costs associated with this collection of information.
The numbers of patents submitted to
FDA for listing in the Orange Book in
2007, 2008, and 2009 were 268, 347,
and 335, respectively, for an annual
average of 317 (268 patents + 347
patents + 335 patents) / 3 years = 317
patents / year). Because many of these
individual patents are included in
multiple NDA submissions, there could
be multiple declarations for a single
patent. From our previous review of
submissions, we believe that
approximately 14 percent of the patents
submitted are included in multiple NDA
submissions, and thus require multiple
patent declarations. Therefore, we
estimate that 44 (317 patents x 14
percent) patents will be multiple
listings, and there will be a total of 361
patents (317 patents + 44 patents = 361
patents) declared on Form FDA 3542.
We approved 67, 73, and 77 NDAs in
2007, 2008, and 2009, respectively, of
which approximately 71% submitted
patent information for listing in the
Orange Book. The remaining NDAs
submitted Form 3542 as required and
declared that there were no relevant
patents. We also approved
approximately 88, 96, and 62 NDA
supplements in 2007, 2008, and 2009,
respectively, for which submission of a
patent declaration would be required.
We estimate there will be 154 instances
(based on an average of 72 NDA
approvals and 82 supplement approvals
per year) where an NDA holder would
be affected by the patent declaration
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16:26 Apr 07, 2010
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requirements, and that each of these
NDA holders would, on average, submit
2.6 declarations ((361 patent
declarations + 45 no relevant patent
declarations) / 154 instances = 2.6
declarations per instance) on Form FDA
3542. We filed 120, 113, and 118 NDAs
in 2007, 2008, and 2009, respectively,
and 145, 99, and 104 NDA supplements
in 2007, 2008, and 2009, respectively,
for which submission of a patent
declaration would be required. We
estimate there will be 233 instances
(based on an average of 117 NDAs filed
and 116 NDA supplements filed per
year) where an NDA holder would be
affected by the patent declaration
requirements. We estimate, based on a
proportional increase from the number
of declarations for approved NDAs, that
there will be an annual total of 606
declarations (233 instances x 2.6
declarations per instance = 606
declarations) on Form FDA 3542a
submitted with these applications.
Based upon information provided by
regulated entities and other information,
we previously estimated that the
information collection burden
associated with Sec. 314.50(h) (citing
Sec. 314.53) and FDA Forms 3542a and
3542 will be approximately 20 hours
and 5 hours per response, respectively.
On December 3, 2008, FDA
announced in the Federal Register (73
FR 73659) the availability of a draft
guidance for industry entitled
‘‘Submission of Patent Information for
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Fmt 4703
Sfmt 4703
Certain Old Antibiotics.’’ That draft
guidance, if finalized, would provide
information regarding FDA’s current
thinking on the implementation of
section 4(b)(1) of the Q1 Program
Supplemental Funding Act (Public Law
110–379). Section 4(b)(1) of the Q1 Act
requires submission to FDA of patent
information by sponsors of certain
NDAs containing old antibiotics.
Estimates on the number of Forms FDA
3542a and 3542 that might be submitted
in accordance with a finalized guidance
have been included in table 1 of this
document.
Dated: April 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–7891 Filed 4–7–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Interstate Administrative
Subpoena.
OMB No.: 0970–0152.
Description: Section 452(a)(11) of the
Social Security Act requires the
Secretary of the Department of Health
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08APN1
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Federal Register / Vol. 75, No. 67 / Thursday, April 8, 2010 / Notices
and Human Services to promulgate a
form for administrative subpoenas to be
used in State child support enforcement
programs to collect information for use
in the establishment, modification and
enforcement of child support orders in
interstate cases. Section 454(9)(E) of the
Social Security Act requires each State
to cooperate with any other State in
using the federal form for issuance of
administrative subpoenas in interstate
child support cases. Tribal IV–D
agencies are not required to use this
form but may choose to do so. OMB
approval of this form is expiring in
February 2011 and the Administration
for Children and Families is requesting
an extension of this form.
Respondents: State, local or Tribal
agencies administering a child support
enforcement program under title IV–D
of the Social Security Act.
ANNUAL BURDEN ESTIMATES
Number of respondents
Number of responses per
respondent
Average burden hours per
response
Administrative Subpoena .................................................................................
35,286
1
0.50
17,643
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
17,643
Instrument
In compliance with the requirements
of section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: April 5, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–7984 Filed 4–7–10; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Total burden
hours
OMB No.: 0970–0153.
Description: Section 452(a)(11) of the
Social Security Act requires the
Secretary of Health and Human Services
to promulgate a form for imposition of
liens to be used by the State child
support enforcement (Title IV–D)
agencies in interstate cases. Section
454(9)(E) of the Social Security Act
requires each State to cooperate with
any other State in using the Federal
form for imposition of liens in interstate
child support cases. Tribal IV–D
agencies are not required to use this
form but may choose to do so. OMB
approval of this form is expiring in
February 2011 and the Administration
for Children and Families is requesting
an extension of this form.
Respondents: State, local or Tribal
agencies administering a child support
enforcement program under title IV–D
of the Social Security Act.
Proposed Projects
Title: Notice of Interstate Lien.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
sroberts on DSKD5P82C1PROD with NOTICES
Notice of Lien ...................................................................................................
Estimated Total Annual Burden
Hours: 458,096.
In compliance with the requirements
of section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
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1,832,384
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
PO 00000
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Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
Average
burden hours
per
response
0.25
Total burden
hours
458,096
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
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]]>Agencies
[Federal Register Volume 75, Number 67 (Thursday, April 8, 2010)]
[Notices]
[Pages 17925-17926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7984]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Interstate Administrative Subpoena.
OMB No.: 0970-0152.
Description: Section 452(a)(11) of the Social Security Act requires
the Secretary of the Department of Health
[[Page 17926]]
and Human Services to promulgate a form for administrative subpoenas to
be used in State child support enforcement programs to collect
information for use in the establishment, modification and enforcement
of child support orders in interstate cases. Section 454(9)(E) of the
Social Security Act requires each State to cooperate with any other
State in using the federal form for issuance of administrative
subpoenas in interstate child support cases. Tribal IV-D agencies are
not required to use this form but may choose to do so. OMB approval of
this form is expiring in February 2011 and the Administration for
Children and Families is requesting an extension of this form.
Respondents: State, local or Tribal agencies administering a child
support enforcement program under title IV-D of the Social Security
Act.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Administrative Subpoena......................... 35,286 1 0.50 17,643
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 17,643
----------------------------------------------------------------------------------------------------------------
In compliance with the requirements of section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Administration, Office of Information Services, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Dated: April 5, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010-7984 Filed 4-7-10; 8:45 am]
BILLING CODE 4184-01-P
