Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet, 41984-41985 [2012-17369]
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Federal Register / Vol. 77, No. 137 / Tuesday, July 17, 2012 / Notices
Notice of information collection
to be submitted to OMB for review and
approval under the Paperwork
Reduction Act.
ACTION:
In accordance with
requirements of the Paperwork
Reduction Act of 1995 (‘‘PRA’’), 44
U.S.C. 3501 et seq., the FDIC may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection unless it displays
a currently valid Office of Management
and Budget (OMB) control number. The
FDIC, as part of its continuing effort to
reduce paperwork and respondent
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on the renewal
of an existing information collection, as
required by the PRA. On April 30, 2012
(77 FR 25479), the FDIC solicited public
comment for a 60-day period on the
renewal of the following information
collection: Notice Regarding Assessment
Credits (OMB No. 3064–0151). No
comments were received. Therefore, the
FDIC hereby gives notice of submission
of its request for renewal to OMB for
review.
SUMMARY:
Comments must be submitted on
or before August 16, 2012.
ADDRESSES: Interested parties are
invited to submit written comments to
the FDIC by any of the following
methods:
• https://www.FDIC.gov/regulations/
laws/federal/notices.html.
• Email: comments@fdic.gov Include
the name of the collection in the subject
line of the message.
• Mail: Gary A. Kuiper
(202.898.3877), Counsel, Room NYA–
5046, Federal Deposit Insurance
Corporation, 550 17th Street NW.,
Washington, DC 20429.
• Hand Delivery: Comments may be
hand-delivered to the guard station at
the rear of the 17th Street Building
(located on F Street), on business days
between 7:00 a.m. and 5:00 p.m.
All comments should refer to the
relevant OMB control number. A copy
of the comments may also be submitted
to the OMB desk officer for the FDIC:
Office of Information and Regulatory
Affairs, Office of Management and
Budget, New Executive Office Building,
Washington, DC 20503.
FOR FURTHER INFORMATION CONTACT: Gary
A. Kuiper, at the FDIC address above.
SUPPLEMENTARY INFORMATION:
Proposal to renew the following
currently-approved collection of
information:
Title: Notice Regarding Assessment
Credits.
OMB Number: 3064–0151.
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DATES:
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Frequency of Response: Once.
Affected Public: FDIC-insured
institutions.
Estimated Number of Respondents: 4.
Estimated Time per Response: 2
hours.
Estimated Total Annual Burden: 8
hours.
General Description of Collection:
FDIC-insured institutions must notify
the FDIC if deposit insurance
assessment credits are transferred, e.g.,
through a sale of the credits or through
a merger, in order to obtain recognition
of the transfer.
Request for Comment
Comments are invited on: (a) Whether
the collection of information is
necessary for the proper performance of
the FDIC’s functions, including whether
the information has practical utility; (b)
the accuracy of the estimates of the
burden of the information collection,
including the validity of the
methodology and assumptions used; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the information collection on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
All comments will become a matter of
public record.
Dated at Washington, DC, this 11th day of
July 2012.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2012–17308 Filed 7–16–12; 8:45 am]
BILLING CODE 6714–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting Notice for the President’s
Advisory Council on Faith-based and
Neighborhood Partnerships
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the President’s
Advisory Council on Faith-based and
Neighborhood Partnerships announces
the following meeting:
Name: President’s Advisory Council on
Faith-based and Neighborhood Partnerships
Council Meeting
Time and Date: Tuesday, July 31st 9:30
a.m.–12:00 p.m. (EST)
Place: Meeting will be held at a location to
be determined in the White House complex,
1600 Pennsylvania Ave NW., Washington,
DC. Space is extremely limited. Photo ID and
RSVP are required to attend the event. Please
RSVP to Ben O’Dell at partnerships@hhs.gov.
There will also be a conference call line
available for those who cannot attend the
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meeting in person. The call-in line is: 1–877–
568–4106, Passcode: 163–296–015.
Status: Open to the public, limited only by
space available. Conference call limited only
by lines available.
Purpose: The Council brings together
leaders and experts in fields related to the
work of faith-based and neighborhood
organizations in order to: Identify best
practices and successful modes of delivering
social services; evaluate the need for
improvements in the implementation and
coordination of public policies relating to
faith- based and other neighborhood
organizations; and make recommendations
for changes in policies, programs, and
practices.
Contact Person for Additional Information:
Please contact Ben O’Dell for any additional
information about the President’s Advisory
Council meeting at partnerships@hhs.gov.
Agenda: Please visit https://
www.whitehouse.gov/partnerships for further
updates on the Agenda for the meeting.
Public Comment: There will be an
opportunity for public comment at the end of
the meeting from 11:30–12 noon (EST).
Comments and questions can be asked over
the conference call line, or sent in advance
to partnerships@hhs.gov.
Dated: July 12, 2012.
Ben O’Dell,
Designated Federal Officer and Associate
Director, HHS Center for Faith-based and
Neighborhood Partnerships.
[FR Doc. 2012–17358 Filed 7–16–12; 8:45 am]
BILLING CODE 4154–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0708]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Form FDA 3728,
Animal Generic Drug User Fee Act
Cover Sheet
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 16,
2012.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
SUMMARY:
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Federal Register / Vol. 77, No. 137 / Tuesday, July 17, 2012 / Notices
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0632. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley II, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Form FDA 3728, Animal Generic Drug
User Fee Act Cover Sheet—21 U.S.C.
379j–21 (OMB Control Number 0910–
0632)—Extension
Section 741 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
379j–21) establishes three different
kinds of user fees: (1) Fees for certain
types of abbreviated applications for
generic new animal drugs, (2) annual
fees for certain generic new animal drug
products, and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). Because the submission of user
fees concurrent with applications is
required, the review of an application
cannot begin until the fee is submitted.
Form FDA 3728 is the Animal Generic
Drug User Fee Act (AGDUFA) Cover
Sheet, which is designed to provide the
minimum necessary information to
determine whether a fee is required for
review of an application, to determine
the amount of the fee required, and to
account for and track user fees.
In the Federal Register of October 5,
2011 (76 FR 61709), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form Number
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
3728 .................................................................
20
2
40
.08 (5 min.)
3.2
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are generic animal drug
applicants. Based on FDA’s database
system, there are an estimated 20
sponsors of new animal drugs
potentially subject to AGDUFA.
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17369 Filed 7–16–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Use of Influenza Disease Models To
Quantitatively Evaluate the Benefits
and Risks of Vaccines: A Technical
Workshop; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: ‘‘Use of Influenza Disease
Models to Quantitatively Evaluate the
Benefits and Risks of Vaccines: A
Technical Workshop.’’ The purpose of
this public workshop is to provide
stakeholders a forum to discuss the
design of a model to quantitatively
estimate the benefits and risks of a
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hypothetical influenza vaccine, and to
seek from a range of experts, feedback
on the current version of the model used
by the Center for Biologics Evaluation
and Research (CBER) and suggestions
for further development.
The public workshop will include
presentations and panel discussions
with experts from academia, regulated
industry, government, and other
stakeholders.
Date and Time: The public workshop
will be held on August 23, 2012, from
9 a.m. to 4 p.m.
Location: The public workshop will
be held at the Bethesda North Marriott
Hotel & Conference Center; 5701
Marinelli Rd., Bethesda, MD 20852;
301–822–9200.
Contact Person: Richard Forshee,
Center for Biologics Evaluation and
Research (HFM–210), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6042, email:
Richard.Forshee@fda.hhs.gov.
Registration: Mail, fax, or email your
registration information (including
name, title, firm name, address,
telephone, and fax numbers, and email
address) to Richard Forshee (see Contact
Person) by August 16, 2012. There is no
registration fee for the public workshop.
Early registration is recommended
because seating is limited. Registration
on the day of the public workshop will
be provided on a space-available basis
beginning at 8 a.m. If you need special
accommodations due to a disability,
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please contact Richard Forshee (see
Contact Person) at least 7 days in
advance.
The
workshop will provide an opportunity
for discussions on the application of
open source influenza infectious disease
computer simulation models to generate
quantitative estimates of the benefits
and risks of influenza vaccination.
The public workshop presentations
and panel discussions will: (1) Discuss
recent developments in open-source,
agent-based, publicly available
computer simulation tools to model
influenza and other infectious diseases;
(2) discuss and seek technical feedback
on the CBER quantitative model of
influenza vaccine benefit/risk; and (3)
discuss possible applications of
quantitative benefit/risk assessment
methods to vaccine assessment of
quantitative benefit/risk assessment
methods to vaccine assessment.
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Notices]
[Pages 41984-41985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17369]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0708]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Form FDA 3728, Animal
Generic Drug User Fee Act Cover Sheet
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
16, 2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs,
[[Page 41985]]
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB
control number 0910-0632. Also include the FDA docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley II, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Form FDA 3728, Animal Generic Drug User Fee Act Cover Sheet--21 U.S.C.
379j-21 (OMB Control Number 0910-0632)--Extension
Section 741 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 379j-21) establishes three different kinds of user fees: (1)
Fees for certain types of abbreviated applications for generic new
animal drugs, (2) annual fees for certain generic new animal drug
products, and (3) annual fees for certain sponsors of abbreviated
applications for generic new animal drugs and/or investigational
submissions for generic new animal drugs (21 U.S.C. 379j-21(a)).
Because the submission of user fees concurrent with applications is
required, the review of an application cannot begin until the fee is
submitted. Form FDA 3728 is the Animal Generic Drug User Fee Act
(AGDUFA) Cover Sheet, which is designed to provide the minimum
necessary information to determine whether a fee is required for review
of an application, to determine the amount of the fee required, and to
account for and track user fees.
In the Federal Register of October 5, 2011 (76 FR 61709), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA Form Number Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
3728..................................................... 20 2 40 .08 (5 min.) 3.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of information are generic animal
drug applicants. Based on FDA's database system, there are an estimated
20 sponsors of new animal drugs potentially subject to AGDUFA.
Dated: July 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17369 Filed 7-16-12; 8:45 am]
BILLING CODE 4160-01-P
