Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug User Fee Cover Sheet; Form FDA 3397, 48689-48690 [2013-19276]
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48689
Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices
submit a non-binding letter of intent by
March 15, 2013, and an application by
May 1, 2013.
On July 17, 2013, we published a
notice in the Federal Register
announcing an extension of deadlines.
The new deadlines were July 19, 2013
for the Letter of Intent and August 1,
2013 for the application.
innovation.cms.gov/initiatives/
comprehensive-ESRD-care.
(No. 93.773 Medicare—Hospital Insurance
Program; and No. 93.774, MedicareSupplementary Medical Insurance Program)
Dated: August 5, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
II. Provisions of the Notice
[FR Doc. 2013–19351 Filed 8–8–13; 8:45 am]
Since the publication of the July 17,
2013 notice, several stakeholders have
requested additional time to prepare
their applications and form
partnerships. Therefore, for the
Comprehensive ESRD Care Initiative,
the Innovation Center is reopening the
Letters of Intent submission period and
extending the deadlines for submission
of both the Letters of Intent and the
Applications to August 30, 2013.
In the DATES section of this notice, we
are including the new submissions
deadlines. For additional information
on the Comprehensive ESRD Care
Model and how to apply, we refer
readers to click on the Request for
Applications located on the Innovation
Center Web site at: https://
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Home Visiting: Approaches to
Father Engagement and Father’s
Experiences.
OMB No.: New Collection.
Description: The Office of Planning,
Research, and Evaluation (OPRE) in the
Administration for Children and
Families (ACF) is proposing an
information collection activity for the
Home Visiting: Approaches to Father
Engagement and Father’s Experiences
Study.
This study will document strategies
used by home visiting programs to
engage and serve fathers and the
perceptions of the fathers regarding the
programs. The findings will be of broad
interest to many home visiting programs
that desire to increase the active
engagement of fathers.
Data collection will involve semistructured discussions and interviews
with administrators and managers of
select home visiting programs as well as
staff about the objectives, experiences,
and specific methods and approaches
used by program operators that have
successfully engaged fathers.
Data collection will also include semistructured discussions and interviews
with invited and/or participating fathers
about their expectations, perceptions,
and opinions of the home visiting
program and experiences with the
program.
Respondents: Administrators and
managers of select home visiting
programs, home visiting staff, and
participating and invited fathers.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
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Discussion Guide for use with Fathers ................................
Discussion Guide for use with Home Visiting Program Administrators, Managers, and Staff ....................................
Estimated Total Annual Burden
Hours: 200.
In compliance with the requirements
of Section 3506(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 Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. Email address:
OPREinfocollection@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
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Annual number of respondents
Number of responses per
respondent
Average burden hours per
response
Annual burden
hours
250
83
1
2
166
50
17
1
2
34
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer, Administration for
Children and Families.
SUMMARY:
[FR Doc. 2013–19337 Filed 8–8–13; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2012–N–0471]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Prescription Drug User Fee Cover
Sheet; Form FDA 3397
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Prescription Drug User Fee Cover
Sheet; Form FDA 3397’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, 1350 Piccard
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09AUN1
48690
Federal Register / Vol. 78, No. 154 / Friday, August 9, 2013 / Notices
Dr., PI50–400B, Rockville, MD 20850,
301–796–7726,
ila.mizrachi@fda.hhs.gov.
On
November 6, 2012, the Agency
submitted a proposed collection of
information entitled ‘‘Prescription Drug
User Fee Cover Sheet; Form FDA 3397’’
to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0297. The
approval expires on December 31, 2015.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–19276 Filed 8–8–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Oncologic Drugs
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 12, 2013, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
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to the White Oak Campus must enter
through Building 1.
Contact Person: Caleb Briggs, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, Fax: 301–847–8533, email:
ODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On September 12, 2013, the
committee will discuss supplemental
biologics license application 125409/51,
with the trade name PERJETA
(pertuzumab) injection, application
submitted by Genentech, Inc. The
proposed indication (use) for this
product is in combination with
trastuzumab and docetaxel for the
neoadjuvant treatment of patients with
human epidermal growth factor receptor
2 (HER2)-positive, locally advanced,
inflammatory, or early stage breast
cancer (tumor greater than 2 cm in
diameter) as part of a complete early
breast cancer regimen containing either
fluorouracil, epirubicin, and
cyclophosphamide or carboplatin.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 28, 2013.
Oral presentations from the public will
be scheduled between approximately
12:30 p.m. and 1:30 p.m. Those
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individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 20, 2013. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 21, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Caleb Briggs
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 2, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–19252 Filed 8–8–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Anti-Infective Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 78, Number 154 (Friday, August 9, 2013)]
[Notices]
[Pages 48689-48690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19276]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0471]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Prescription Drug User Fee Cover
Sheet; Form FDA 3397
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Prescription Drug User Fee Cover
Sheet; Form FDA 3397'' has been approved by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, 1350 Piccard
[[Page 48690]]
Dr., PI50-400B, Rockville, MD 20850, 301-796-7726,
ila.mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On November 6, 2012, the Agency submitted a
proposed collection of information entitled ``Prescription Drug User
Fee Cover Sheet; Form FDA 3397'' to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0297.
The approval expires on December 31, 2015. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19276 Filed 8-8-13; 8:45 am]
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