Agency Information Collection Activities; Proposed Collection; Comment Request; FDA Form 3728, Animal Generic Drug User Fee Act Cover Sheet, 61709-61710 [2011-25708]
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61709
Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component
Total cost
Annualized
cost
Data Processing and Analysis .................................................................................................................................
Overhead .................................................................................................................................................................
31,220
22,034
10,406
7,345
Total ..................................................................................................................................................................
178,137
59,379
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: September 26, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–25693 Filed 10–4–11; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0708]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA Form 3728,
Animal Generic Drug User Fee Act
Cover Sheet
mstockstill on DSK4VPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
SUMMARY:
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19:11 Oct 04, 2011
Jkt 226001
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish a notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection burden of the
Animal Generic Drug User Fee Cover
Sheet Form FDA 3728 that further
implements certain provisions of the
Animal Generic Drug User Fee Act of
2008 (AGDUFA).
DATES: Submit either electronic or
written comments on the collection of
information by December 5, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
Juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
PO 00000
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Sfmt 4703
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
FDA Form 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.
FDA Form 3728 is the 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. FDA
estimates the burden of this collection
of information as follows:
E:\FR\FM\05OCN1.SGM
05OCN1
61710
Federal Register / Vol. 76, No. 193 / Wednesday, October 5, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
FDA Form 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 data base
system, there are an estimated 20
sponsors of new animal drugs
potentially subject to AGDUFA.
Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25708 Filed 10–4–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0423]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements for
Submission of Bioequivalence Data
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 November
4, 2011.
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:
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0630. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Juanmanuel Vilela, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–7651,
juanmanuel.vilela@fda.hhs.gov.
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.
Requirements for Submission of
Bioequivalence Data—21 CFR Parts 314
and 320—(OMB Control Number 0910–
0630)—Extension
In the Federal Register of January 16,
2009 (74 FR 2849), the Agency
published a final rule revising FDA
regulations to require applicants to
submit data on all bioequivalence (BE)
studies, including studies that do not
meet passing BE criteria, which are
performed on a drug product
formulation submitted for approval
under an abbreviated new drug
application (ANDA), or in an
amendment to an ANDA that contains
BE studies. In the final rule, FDA
amended §§ 314.94(a)(7)(i), 314.96(a)(1),
314.97, and 320.21(b)(1), to require an
ANDA applicant to submit information
from all BE studies, both passing and
nonpassing, conducted by the applicant
on the same drug product formulation
as that submitted for approval under an
ANDA, amendment, or supplement.
In table 1 of this document, FDA has
estimated the reporting burden
associated with each section of the rule.
FDA believes that the majority of
additional BE studies will be reported in
ANDAs (submitted under § 314.94),
rather than supplements (reported in
§ 314.97), because it is unlikely than an
ANDA holder will conduct BE studies
with a drug after the drug has been
approved. With respect to the reporting
of additional BE studies in amendments
(submitted under § 314.96), this should
also account for a small number of
reports, because most BE studies will be
conducted on a drug prior to the
submission of the ANDA, and will be
reported in the ANDA itself.
FDA estimates it will require
approximately 120 hours of staff time to
prepare and submit each additional
complete BE study report, and
approximately 60 hours of staff time for
each additional BE summary report. The
Agency believes that a complete report
will be required approximately 20
percent of the time, while a summary
will suffice approximately 80 percent of
the time. Based on a weighted-average
calculation using the information
presented above, the submission of each
additional BE study is expected to take
72 hours of staff time ([120 × 0.2] + [60
× 0.8]).
In the Federal Register of June 10,
2011 (76 FR 34081), 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 respondents
Number of responses per
respondent
314.94(a)(7) .........................................................................
314.96(a)(1) .........................................................................
314.97 ..................................................................................
49
1
1
1
1
1
49
1
1
72
72
72
3,528
72
72
Total ..............................................................................
........................
........................
........................
........................
3,672
mstockstill on DSK4VPTVN1PROD with NOTICES
21 CFR Section
1 There
Total annual
responses
are no capital costs or operating and maintenance costs associated with this collection of information.
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05OCN1
Average burden per response
Total hours
]]>Agencies
[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Notices]
[Pages 61709-61710]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25708]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0708]
Agency Information Collection Activities; Proposed Collection;
Comment Request; FDA Form 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 an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish a notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728
that further implements certain provisions of the Animal Generic Drug
User Fee Act of 2008 (AGDUFA).
DATES: Submit either electronic or written comments on the collection
of information by December 5, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
Juanmanuel.vilela@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
FDA Form 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. FDA Form 3728 is the 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. FDA estimates
the burden of this collection of information as follows:
[[Page 61710]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDA Form 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 data base system, there are an
estimated 20 sponsors of new animal drugs potentially subject to
AGDUFA.
Dated: September 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25708 Filed 10-4-11; 8:45 am]
BILLING CODE 4160-01-P
