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; Extension, 52930-52931 [2013-20821]
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tkelley on DSK3SPTVN1PROD with NOTICES
52930
Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Notices
https://www.effective
healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?page
action=displayproduct
&productID=1620.
This notice is to notify the public that
the EHC program would find the
following information on imaging tests
for the diagnosis and staging of
pancreatic adenocarcinoma helpful:
D A list of completed studies your
company has sponsored for this
indication. In the list, indicate whether
results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: Study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
D A list of ongoing studies your
company has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
company for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. The contents of all
submissions will be made available to
the public upon request. Materials
submitted must be publicly available or
can be made public. Materials that are
considered confidential; marketing
materials; study types not included in
the review; or information on
indications not included in the review
cannot be used by the Effective Health
Care Program. This is a voluntary
request for information, and all costs for
complying with this request must be
borne by the submitter.
The draft of this review will be posted
on AHRQ’s EHC program Web site and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.AHRQ.gov/
index.cfm/join-the-email-list1/.
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15:54 Aug 26, 2013
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The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions. The entire
research protocol, is also available
online at: https://www.effective
healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/?page
action=displayproduct&product
ID=1620.
The Key Questions
Question 1
What is the comparative effectiveness
of imaging techniques (e.g., MDCT
angiography ± 3D reconstruction, other
MDCT, EUS–FNA, PET–CT, MRI) for
diagnosis of pancreatic adenocarcinoma
in adults with suspicious symptoms?
a. What is the accuracy of each
imaging technique for diagnosis and
assessment of resectability?
b. What is the comparative accuracy
of the different imaging techniques for
diagnosis and assessment of
resectability?
c. What is the comparative diagnostic
accuracy of using a single imaging
technique versus using multiple
imaging techniques?
d. How is test experience (e.g.,
operative experience, assessor
experience, center’s annual volume)
related to comparative diagnostic
accuracy of the different imaging
strategies?
e. How are patient factors and tumor
characteristics related to the
comparative diagnostic accuracy of the
different imaging strategies?
f. What is the comparative clinical
management after the different imaging
strategies when used for diagnosis?
What is the comparative impact of the
different imaging strategies on long-term
survival and quality of life when used
for diagnosis?
Question 2
What is the comparative effectiveness
of imaging techniques (e.g., MDCT
angiography ± 3D reconstruction, other
MDCT, EUS–FNA, PET–CT, MRI) for
staging of pancreatic adenocarcinoma
among adults with a diagnosis of
pancreatic adenocarcinoma?
a. What is the staging accuracy of each
imaging technique (for tumor size,
lymph node status, vessel involvement,
metastases, stage [I–IV], and
resectability)?
b. What is the comparative staging
accuracy among the different imaging
techniques?
c. What is the comparative staging
accuracy of using a single imaging
technique versus using multiple
imaging techniques?
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d. How is test experience (e.g.,
operative experience, assessor
experience, center’s annual volume)
related to comparative staging accuracy
of the different imaging strategies?
e. How are patient factors and tumor
characteristics related to the
comparative staging accuracy of the
different imaging strategies?
f. What is the comparative clinical
management of the different imaging
strategies when used for staging?
What is the comparative impact of the
different imaging strategies on long-term
survival and quality of life when used
for staging?
Question 3
What are the rates of harms of imaging
techniques (e.g., MDCT angiography ±
3D reconstruction, other MDCT, EUS–
FNA, PET–CT, MRI) when used to
diagnose and/or stage pancreatic
adenocarcinoma?
a. How are patient factors related to
the harms of different imaging
techniques?
What are patient perspectives on the
tolerance of different imaging
techniques and the balance of benefits
and harms of different imaging
techniques?
Question 4
What is the comparative screening
accuracy of imaging techniques (e.g.,
MDCT angiography ± 3D reconstruction,
other MDCT, EUS–FNA, PET–CT, MRI)
in high-risk asymptomatic adults (i.e.,
those at genetic or familial risk of
pancreatic adenocarcinoma)?
Dated: August 19, 2013.
Carolyn M. Clancy,
AHRQ, Director.
[FR Doc. 2013–20849 Filed 8–26–13; 8:45 am]
BILLING CODE 4160–90–P
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; Extension
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
E:\FR\FM\27AUN1.SGM
27AUN1
52931
Federal Register / Vol. 78, No. 166 / Tuesday, August 27, 2013 / Notices
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 September
26, 2013.
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 and
title ‘‘Substances Prohibited From Use
in Animal Food or Feed; Animal
Proteins Prohibited in Ruminant Feed.’’
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, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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
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 May 16,
2013 (78 FR 28852), 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 RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Maintaining written procedures (§ 589.2000 (e)(1)(iv)) ........
400
1
400
14
5,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20821 Filed 8–26–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0938]
tkelley on DSK3SPTVN1PROD with NOTICES
Draft Guidance for Industry on
Abbreviated New Drug Applications:
Stability Testing of Drug Substances
and Products, Questions and Answers;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘ANDAs: Stability
SUMMARY:
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15:54 Aug 26, 2013
Jkt 229001
Testing of Drug Substances and
Products, Questions and Answers.’’ This
draft guidance clarifies stability testing
recommendations for abbreviated new
drug applications (ANDAs) by providing
responses to public comments in a
questions-and-answers format. This
draft guidance addresses public
comments regarding FDA’s
recommendation to generic drug
manufacturers to follow International
Conference on Hamonisation (ICH)
stability guidances Q1A (R2) through
Q1E.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 28,
2013.
DATES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
ADDRESSES:
PO 00000
Frm 00036
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Sfmt 4703
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Radhika Rajagopalan, Center for Drug
Evaluation and Research (HFD–640),
Food and Drug Administration, 7500
Standish Pl., MPN2, Rm. 243, Rockville,
MD 20855, 240–276–8546.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\27AUN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52930-52931]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20821]
-----------------------------------------------------------------------
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; Extension
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of
[[Page 52931]]
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
September 26, 2013.
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 and
title ``Substances Prohibited From Use in Animal Food or Feed; Animal
Proteins Prohibited in Ruminant Feed.'' 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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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 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 May 16, 2013 (78 FR 28852), 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 Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintaining written procedures (Sec. 589.2000 (e)(1)(iv))........ 400 1 400 14 5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20821 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-01-P
