Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728, 27802 [E9-13716]
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27802
Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
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: June 8, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–13684 Filed 6–10–09; 8:45 am]
BILLING CODE 4184–01–P
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0572]
Implementation of the Animal Generic
Drug User Fee Act of 2008; User Fee
Cover Sheet Form FDA 3728—21 U.S.C.
379j-21 (OMB Control Number 0910–
0632)—Extension
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Implementation of
the Animal Generic Drug User Fee Act
of 2008; User Fee Cover Sheet Form
FDA 3728
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
(the PRA).
DATES: Fax written comments on the
collection of information by July 13,
2009.
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,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed 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 Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
This collection of information is
currently approved under the
emergency processing provisions of the
PRA for 180 days. FDA is now seeking
a 3-year clearance.
Section 741 of the act (21 U.S.C. 379j21), 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. Because the submission of user
fees concurrently with applications is
required, the review of an application
cannot begin until the fee is submitted.
Form FDA 3728, the Animal Generic
Drug User Fee Cover Sheet, is designed
to provide the minimum necessary
information in order to do the following:
(1) Determine whether a fee is required
for review of an application, (2)
determine the amount of fee required,
and (3) account for and track user fees.
In the Federal Register of March 11,
2009 (74 FR 10596), FDA published a
60-day notice requesting public
comment on the information collection
provisions. No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 U.S.C.
379j-21
Form FDA
3728
jlentini on PROD1PC65 with NOTICES
1 There
Annual Frequency per
Response
No. of Respondents
20
Total Annual Responses
2
Hours per Response
40
Total Hours
.08
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 the Animal
Generic Drug User Fee Act of 2008.
Dated: June 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–13716 Filed 6–10–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4160–01–S
Submission for OMB Review;
Comment Request
Administration for Children and
Families
Title: Performance Progress Report.
OMB No.: 0970–0334.
VerDate Nov<24>2008
16:37 Jun 10, 2009
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Agencies
[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Page 27802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13716]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0572]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Implementation of the
Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA
3728
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 (the PRA).
DATES: Fax written comments on the collection of information by July
13, 2009.
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, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed 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 Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 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.
Implementation of the Animal Generic Drug User Fee Act of 2008; User
Fee Cover Sheet Form FDA 3728--21 U.S.C. 379j-21 (OMB Control Number
0910-0632)--Extension
This collection of information is currently approved under the
emergency processing provisions of the PRA for 180 days. FDA is now
seeking a 3-year clearance.
Section 741 of the 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. Because
the submission of user fees concurrently with applications is required,
the review of an application cannot begin until the fee is submitted.
Form FDA 3728, the Animal Generic Drug User Fee Cover Sheet, is
designed to provide the minimum necessary information in order to do
the following: (1) Determine whether a fee is required for review of an
application, (2) determine the amount of fee required, and (3) account
for and track user fees.
In the Federal Register of March 11, 2009 (74 FR 10596), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per
21 U.S.C. 379j-21 No. of Respondents Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FDA 3728 20 2 40 .08 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 the Animal
Generic Drug User Fee Act of 2008.
Dated: June 3, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13716 Filed 6-10-09; 8:45 am]
BILLING CODE 4160-01-S