Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed, 60706-60707 [2016-21157]
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60706
Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
include the FDA docket number found
in brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
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:
Abbreviated New Animal Drug
Applications—Sections (b)(2) and (n)(1)
of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1))—OMB Control Number 0910–
0669—Extension
Under section 512(b)(2) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act), any person may file an
abbreviated new animal drug
application (ANADA) seeking approval
of a generic copy of an approved new
animal drug. The information required
to be submitted as part of an ANADA is
described in section 512(n)(1) of the
FD&C Act. Among other things, an
ANADA is required to contain
information to show that the proposed
generic drug is bioequivalent to, and has
the same labeling as, the approved new
animal drug. We use the information
submitted, among other things, to assess
bioequivalence to the originally
approved drug and thus, the safety and
effectiveness of the generic new animal
drug. We allow applicants to submit a
complete ANADA or to submit
information in support of an ANADA
for phased review. Applicants may
submit Form FDA 356v with a complete
ANADA or a phased review submission
to ensure efficient and accurate
processing of information.
In the Federal Register of May 11,
2016 (81 FR 29273), 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
Total
annual
responses
Average
burden
per
response
FDA
Form
ANADA .................................................................................
Phased Review with Administrative ANADA .......................
356v .......
356v .......
18
3
1
5
18
15
159
31.8
2,862
477
Total ..............................................................................
................
....................
....................
....................
....................
3,339
1 There
Number of
respondents
Number of
responses
per
respondent
FD&C Act sections 512(b)(2) and (n)(1)
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimates on our
experience with ANADA submissions
and requests for phased review. We
estimate that we will receive 21 ANADA
submissions per year over the next three
years and that three of those
submissions will request phased review.
We estimate that each applicant that
uses the phased review process will
have approximately five phased reviews
per application. We estimate that an
applicant will take approximately 159
hours to prepare either an ANADA or
the estimated 5 ANADA phased review
submissions and the administrative
ANADA.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
SUMMARY:
[FR Doc. 2016–21128 Filed 9–1–16; 8:45 am]
BILLING CODE 4164–01–P
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Food and Drug Administration
[Docket No. FDA–2013–N–0520]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Substances
Prohibited From Use in Animal Food or
Feed; Animal Proteins Prohibited in
Ruminant Feed
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 October 3,
2016.
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:
PO 00000
Frm 00038
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202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0339. Also
include the FDA 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, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, 20852, PRAStaff@
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.
Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed—21 CFR
589.2000(e)(1)(iv) OMB Control Number
0910–0339—Extension
This information collection was
established because epidemiological
evidence gathered in the United
Kingdom suggested that bovine
spongiform encephalopathy (BSE), a
progressively degenerative central
nervous system disease, is spread to
ruminant animals by feeding protein
derived from ruminants infected with
E:\FR\FM\02SEN1.SGM
02SEN1
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’’).
PO 00000
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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
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]]>Agencies
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60706-60707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21157]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0520]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Substances Prohibited
From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant
Feed
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 October
3, 2016.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0339.
Also include the FDA 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, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, 20852, PRAStaff@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.
Substances Prohibited From Use in Animal Food or Feed; Animal Proteins
Prohibited in Ruminant Feed--21 CFR 589.2000(e)(1)(iv) OMB Control
Number 0910-0339--Extension
This information collection was established because epidemiological
evidence gathered in the United Kingdom suggested that bovine
spongiform encephalopathy (BSE), a progressively degenerative central
nervous system disease, is spread to ruminant animals by feeding
protein derived from ruminants infected with
[[Page 60707]]
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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
[FR Doc. 2016-21157 Filed 9-1-16; 8:45 am]
BILLING CODE 4164-01-P
