Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Generic Drug User Fee Act Cover Sheet, 60707-60708 [2016-21177]
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Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
BSE. This regulation places general
requirements on persons that
manufacture, blend, process, and
distribute products that contain, or may
contain, protein derived from
mammalian tissue, and feeds made from
such products.
Specifically, this regulation requires
renderers, feed manufacturers, and
others involved in feed and feed
ingredient manufacturing and
distribution to maintain written
procedures specifying the cleanout
procedures or other means, and
specifying the procedures for separating
products that contain or may contain
protein derived from mammalian tissue
from all other protein products from the
time of receipt until the time of
shipment. These written procedures are
intended to help the firm formalize their
processes, and then to help inspection
personnel confirm that the firm is
operating in compliance with the
regulation. Inspection personnel will
evaluate the written procedure and
confirm it is being followed when they
are conducting an inspection.
These written procedures must be
maintained as long as the facility is
operating in a manner that necessitates
the record, and if the facility makes
60707
changes to an applicable procedure or
process the record must be updated.
Written procedures required by this
section shall be made available for
inspection and copying by FDA.
In the Federal Register of March 15,
2016 (81 FR 13803), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment; however, it did not pertain to
the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR Section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
589.2000(e)(1)(iv); written procedures ................................
320
1
320
14
4,480
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the number
of recordkeepers on inspectional data,
which reflect a decline in the number of
recordkeepers. We attribute this decline
to a reduction in the number of firms
handling animal protein for use in
animal feed.
Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0655]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Generic
Drug User Fee Act Cover Sheet
Food and Drug Administration,
HHS.
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
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SUMMARY:
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You may submit comments
as follows:
BILLING CODE 4164–01–P
ACTION:
Submit either electronic or
written comments on the collection of
information by November 1, 2016.
DATES:
ADDRESSES:
[FR Doc. 2016–21157 Filed 9–1–16; 8:45 am]
AGENCY:
notice. This notice solicits comments on
the information collection requirements
of the Animal Generic Drug User Fee
Act (AGDUFA) cover sheet.
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submission): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0655 for ‘‘Animal Generic Drug
User Fee Act Cover Sheet.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
E:\FR\FM\02SEN1.SGM
02SEN1
60708
Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
FOR FURTHER INFORMATION CONTACT:
St., North Bethesda, MD 20852,
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.
Form FDA 3728, Animal Generic 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 (the 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 concurrent submission
of user fees with applications is
required, the review of an application
cannot begin until the fee is submitted.
Form FDA 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Form FDA No.
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 data base
system, there are an estimated 20
sponsors of new animal drugs
potentially subject to AGDUFA.
Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21177 Filed 9–1–16; 8:45 am]
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Countermeasures Injury
Compensation Program
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
SUMMARY:
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review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
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]]>Agencies
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60707-60708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21177]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0655]
Agency Information Collection Activities; Proposed Collection;
Comment Request; 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 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
requirements of the Animal Generic Drug User Fee Act (AGDUFA) cover
sheet.
DATES: Submit either electronic or written comments on the collection
of information by November 1, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper submission):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0655 for ``Animal Generic Drug User Fee Act Cover Sheet.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
[[Page 60708]]
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Form FDA 3728, Animal Generic 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 (the 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 concurrent submission of user fees with
applications is required, the review of an application cannot begin
until the fee is submitted. Form FDA 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:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Form FDA No. 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 data base system, there are an
estimated 20 sponsors of new animal drugs potentially subject to
AGDUFA.
Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21177 Filed 9-1-16; 8:45 am]
BILLING CODE 4164-01-P
