[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Notices]
[Pages 41984-41985]
From the Federal Register Online via the Government Publishing 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 [email protected]. 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