Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Act Cover Sheet, 6199-6200 [2014-02190]
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6199
Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Notices
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.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–02175 Filed 1–31–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0078]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug User
Fee Act Cover Sheet
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
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish 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 paperwork burden of animal drug
sponsors to fill out the Animal Drug
User Fee Act (ADUFA) cover sheet.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by April 4, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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
DATES:
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.
Animal Drug User Fee Cover Sheet—
(OMB Control Number 0910–0539)—
Extension
Under section 740 of the FD&C Act
(21 U.S.C. 379j-12), as amended by
ADUFA (Pub. L. 108–130), FDA has the
authority to assess and collect for
certain animal drug user fees. Because
the submission of user fees concurrently
with applications and supplements is
required, review of an application
cannot begin until the fee is submitted.
The types of fees that require a cover
sheet are certain animal drug
application fees and certain
supplemental animal drug application
fees. The ADUFA cover sheet (Form
FDA 3546) is designed to provide the
minimum necessary information to
determine whether a fee is required for
the review of an application or
supplement, to determine the amount of
the fee required, and to assure that each
animal drug user fee payment and each
animal drug application for which
payment is made is appropriately linked
to the payment that is made. The form,
when completed electronically, will
result in the generation of a unique
payment identification number used in
tracking the payment. FDA will use the
information collected to initiate
administrative screening of new animal
drug applications and supplements to
determine if payment has been received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA Form No.
740(a)(1) .......................
mstockstill on DSK4VPTVN1PROD with NOTICES
FD&C Act section
amended by ADUFA
3546 (Cover Sheet) ....
1There
Number of
respondents
17
Number of responses
per respondent
Total annual
responses
1 time for each application.
17
Average
burden per
response
Total hours
1
17
are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of
information are new animal drug
applicants or manufacturers. Based on
FDA’s database system, there are an
estimated 173 manufacturers of
products or sponsors of new animal
VerDate Mar<15>2010
20:46 Jan 31, 2014
Jkt 232001
drugs potentially subject to ADUFA.
However, not all manufacturers or
sponsors will have any submissions in
a given year and some may have
multiple submissions. The total number
of annual responses is based on the
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
average number of submissions received
by FDA in fiscal years 2011–13. The
estimated hours per response are based
on past FDA experience with the
various submissions. The hours per
E:\FR\FM\03FEN1.SGM
03FEN1
6200
Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Notices
response are based on the average of
these estimates.
Dated: January 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02190 Filed 1–31–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0017]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary National
Retail Food Regulatory Program
Standards
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
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish 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 provisions of
the Voluntary National Retail Food
Regulatory Program Standards.
DATES: Submit either electronic or
written comments on the collection of
information by April 4, 2014.
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.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
20:46 Jan 31, 2014
Jkt 232001
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.
Voluntary National Retail Food
Regulatory Program Standards (OMB
Control Number 0910–0621—Extension)
The Voluntary National Retail Food
Regulatory Program Standards (the
Program Standards) define nine
essential elements of an effective
regulatory program for retail food
establishments, establish basic quality
control criteria for each element, and
provide a means of recognition for those
State, local, territorial, tribal and
Federal regulatory programs that meet
the Program Standards. The program
elements addressed by the Program
Standards are as follows: (1) Regulatory
foundation; (2) trained regulatory staff;
(3) inspection program based on Hazard
Analysis and Critical Control Point
(HACCP) principles; (4) uniform
inspection program, (5) foodborne
illness and food defense preparedness
and response; (6) compliance and
enforcement; (7) industry and
community relations; (8) program
support and resources; and (9) program
assessment. Each standard includes a
list of records needed to document
conformance with the standard (referred
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
to in the Program Standards document
as ‘‘quality records’’) and has one or
more corresponding forms and
worksheets to facilitate the collection of
information needed to assess the retail
food regulatory program against that
standard. The respondents are State,
local, territorial, tribal, and potentially
other Federal regulatory agencies.
Regulatory agencies may use existing
available records or may choose to
develop and use alternate forms and
worksheets that capture the same
information.
In the course of their normal
activities, State, local, territorial, tribal,
and Federal regulatory agencies already
collect and keep on file many of the
records needed as quality records to
document compliance with each of the
Program Standards. Although the detail
and format in which this information is
collected and recorded may vary by
jurisdiction, records that are kept as a
usual and customary part of normal
agency activities include inspection
records, written quality assurance
procedures, records of quality assurance
checks, staff training certificates and
other training records, a log or database
of food-related illness or injury
complaints, records of investigations
resulting from such complaints, an
inventory of inspection equipment,
records of outside audits, and records of
outreach efforts (e.g., meeting agendas
and minutes, documentation of food
safety education activities). No new
recordkeeping burden is associated with
these existing records, which are
already a part of usual and customary
program recordkeeping activities by
State, local, territorial, tribal and
Federal regulatory agencies, and which
can serve as quality records under the
Program Standards.
State, local, territorial, tribal and
Federal regulatory agencies that enroll
in the Program Standards and seek
listing in the FDA National Registry are
required to report to FDA on the
completion of the following three
management tasks outlined in the
Program Standards: (1) Conducting a
program self-assessment; (2) conducting
a risk factor study of the regulated
industry; and (3) obtaining an
independent outside audit (verification
audit). The results are reported to FDA
on Form FDA 3519, ‘‘FDA National
Registry Report’’ and Form FDA 3520,
‘‘Permission to Publish in National
Registry.’’ These forms are provided in
the Program Standards document, and
are also provided on FDA’s Web site at:
https://www.fda.gov/Food/
GuidanceRegulation/
RetailFoodProtection/
ProgramStandards/default.htm. If a
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Notices]
[Pages 6199-6200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02190]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0078]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal 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 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 paperwork burden of animal
drug sponsors to fill out the Animal Drug User Fee Act (ADUFA) cover
sheet.
DATES: Submit either electronic or written comments on the collection
of information by April 4, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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.
Animal Drug User Fee Cover Sheet--(OMB Control Number 0910-0539)--
Extension
Under section 740 of the FD&C Act (21 U.S.C. 379j-12), as amended
by ADUFA (Pub. L. 108-130), FDA has the authority to assess and collect
for certain animal drug user fees. Because the submission of user fees
concurrently with applications and supplements is required, review of
an application cannot begin until the fee is submitted. The types of
fees that require a cover sheet are certain animal drug application
fees and certain supplemental animal drug application fees. The ADUFA
cover sheet (Form FDA 3546) is designed to provide the minimum
necessary information to determine whether a fee is required for the
review of an application or supplement, to determine the amount of the
fee required, and to assure that each animal drug user fee payment and
each animal drug application for which payment is made is appropriately
linked to the payment that is made. The form, when completed
electronically, will result in the generation of a unique payment
identification number used in tracking the payment. FDA will use the
information collected to initiate administrative screening of new
animal drug applications and supplements to determine if payment has
been received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of responses per Total annual Average burden
FD&C Act section amended by ADUFA FDA Form No. respondents respondent responses per response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
740(a)(1)............................ 3546 (Cover Sheet)...... 17 1 time for each 17 1 17
application.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Respondents to this collection of information are new animal drug
applicants or manufacturers. Based on FDA's database system, there are
an estimated 173 manufacturers of products or sponsors of new animal
drugs potentially subject to ADUFA. However, not all manufacturers or
sponsors will have any submissions in a given year and some may have
multiple submissions. The total number of annual responses is based on
the average number of submissions received by FDA in fiscal years 2011-
13. The estimated hours per response are based on past FDA experience
with the various submissions. The hours per
[[Page 6200]]
response are based on the average of these estimates.
Dated: January 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02190 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P
