Submission for OMB Review; 30-Day comment request; Generic Clearance for Satisfaction Surveys of Customers (CSR), 74730-74731 [2014-29460]
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Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices
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10.115(g)(5)), to ensure that FDA
considers your comment on this draft
CPG before it begins work on the final
version of the CPG, submit either
electronic or written comments on the
draft CPG by February 17, 2015.
ADDRESSES: Submit written requests for
single copies of the draft CPG to the
Office of Policy and Risk Management,
Office of Regulatory Affairs, Office of
Global Regulatory Operations and
Policy, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857. Send two self-addressed
adhesive labels to assist that office in
processing your request. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the CPG.
Submit electronic comments on the
draft CPG to https://www.regulations.gov.
Submit written comments on the draft
CPG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mary E. Losikoff, Center for Food Safety
and Applied Nutrition (HFS–325), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2300.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
the draft CPG entitled ‘‘Compliance
Policy Guide Sec. 540.275 Crabmeat—
Fresh and Frozen—Adulteration with
Filth, Involving the Presence of
Escherichia coli.’’ The draft CPG, when
finalized, will update the previously
issued ‘‘CPG Sec. 540.275 Crabmeat—
Fresh and Frozen—Adulteration with
Filth, Involving the Presence of the
Organism Escherichia coli,’’ which
provides guidance for FDA staff on the
level of E. coli in crabmeat (i.e., 3.6 Most
Probable Number per gram (MPN/g) of
E. coli) at which FDA may consider the
crabmeat to be adulterated with filth
under section 402(a)(4) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 342(a)(4)). We
revised the CPG for clarity and to
update the format. Revisions generally
include the addition of sections on
Background and Policy, updates to the
sections on Regulatory Action Guidance
and Specimen Charges, and FDA office
names. Specifically, in the section on
Regulatory Action Guidance, we clarify
that FDA’s Districts have direct
reference authority for both domestic
seizure and import refusal based on the
criteria described in the draft CPG. We
also clarify the specific types of legal
action to which the criteria for
recommendations apply. In addition, we
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provide specimen charges relating to
domestic seizure and import refusal.
The draft CPG also contains information
that may be useful to the regulated
industry and to the public.
We are issuing the draft CPG
consistent with our good guidance
practices regulation (21 CFR 10.115).
The draft CPG, when finalized, will
represent our current thinking on the
level of E. coli in fresh or frozen
crabmeat at which we may consider the
crabmeat to be adulterated with filth
under section 402(a)(4) of the FD&C Act.
The draft CPG does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternate approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
electronic comments regarding the draft
CPG to https://www.regulations.gov or
written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document from FDA’s
Office of Regulatory Affairs CPG history
page at https://www.fda.gov/ICECI/
ComplianceManuals/CompliancePolicy
GuidanceManual/default.htm or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1697]
Privacy Act of 1974; Report of a New
System of Records; Food and Drug
Administration Commissioning of
State and Local Officials; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of December 8, 2014. The
document misstated the effective date of
the new system of records. This notice
corrects that error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Regulations Editorial
Section, Regulations Policy and
Management Staff, Office of Policy,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–9148.
SUPPLEMENTARY INFORMATION: The
December 8, 2014 (79 FR 72687) notice
published with an incorrect effective
date of December 8, 2014, for the new
system of records. This document
corrects that error. For the convenience
of the reader, the complete DATES
language is set out below.
In 79 FR 72687, published on
December 8, 2014, we are correcting the
DATES section to read as follows:
DATES: Effective Date: The new system
of records and related routine uses will
be effective on January 22, 2015. Submit
either electronic or written comments
by January 22, 2015.
SUMMARY:
Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–29424 Filed 12–15–14; 8:45 am]
BILLING CODE 4164–01–P
Dated: December 10, 2014.
Melinda K. Plaisier,
Associate Commissioner for Regulatory
Affairs, Office of Regulatory Affairs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–29314 Filed 12–15–14; 8:45 am]
Submission for OMB Review; 30-Day
comment request; Generic Clearance
for Satisfaction Surveys of Customers
(CSR)
BILLING CODE 4164–01–P
PO 00000
National Institutes of Health
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
SUMMARY:
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74731
Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Notices
listed below. This proposed information
collection was previously published in
the Federal Register on August 21,
2014, page 49523 and allowed 60 days
for public comment. No public
comments were received. The purpose
of this notice is to request an additional
30 days for public comment and
reinstatement without change. The
Center for Scientific Review (CSR),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 31, 2014, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
outside influence, timely; and (4) to
develop new modes of operation based
on customer need and customer
feedback about the efficacy of
implemented modifications. These
surveys will almost certainly lead to
quality improvement activities to
enhance and/or streamline CSR’s
operations. The major mechanism by
which CSR will request input is through
surveys. The major initiatives ongoing at
the present time include: Evaluation of
the peer review process, surveys of new
and early stage investigators,
satisfaction with study section meetings
using alternative review platforms,
quick feedback for peer review,
satisfaction with new reviewer
orientation sessions, teleworker space
needs, improving study section
alignment to ensure the best reviews,
and others. Surveys will be collected via
Internet or in focus groups. Information
gathered from these surveys will be
presented to, and used directly by, CSR
management to enhance the operations,
processes, organization of, and services
provided by the Center.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4323.
plans and instruments, submit
comments in writing, or request more
information on the proposed project
contact: Dr. Mary Ann Guadagno,
Project Clearance Liaison, Center for
Scientific Review, NIH, Room 3182,
6701 Rockledge Drive, Bethesda, MD
20892, or call non-toll-free number (301)
435–1251 or Email your request,
including your address to: guadagma@
csr.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
Proposed Collection: Generic
Clearance for Satisfaction Surveys of
Customers (CSR), 0925–0474 expired
October 31, 2014-reinstatement without
change, Center for Scientific Review
(CSR), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The information collected in
these surveys will be used by the Center
for Scientific Review management and
personnel: (1) To assess the quality of
the modified operations and processes
now used by CSR to review grant
applications; (2) to assess the quality of
service provided by CSR to our
customers; (3) to enable identification of
the most promising biomedical research
that will have the greatest impact on
improving public health by using a peer
review process that is fair unbiased from
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Type of respondent
A ..................
B ..................
Adult scientific professionals (via Mail/Telephone/Internet) ..
Adult scientific professionals (via focus groups) ...................
Dated: December 10, 2014.
Mary Ann Guadagno,
Project Clearance Liaison, Center for
Scientific Review, National Institutes of
Health.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
SUMMARY:
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19:38 Dec 15, 2014
Jkt 235001
7925
240
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
[FR Doc. 2014–29460 Filed 12–15–14; 8:45 am]
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
PO 00000
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Number of
responses per
respondent
1
1
Average
burden per
response
(in hours)
Total annual
burden hours
30/60
90/60
3963
360
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
Microscopy System for Distinguishing
Stimulated Emissions as a Means of
Increasing Signal
Description of Technology: The
invention pertains to a system and
method for distinguishing stimulated
emissions as a means of enhancing
signal strength of fluorescent markers in
fluorescence microscopy applications.
The system is arranged such that an
excitation beam (e.g., laser beam)
illuminates a sample along some axis
exciting the fluorescent markers used in
the sample. A second light beam, a
stimulation beam, illuminates the
sample along another axis, possibly the
same as that of the excitation beam. It
has been found that if the excited
fluorescent molecules are illuminated
with light of a stimulation beam at a
E:\FR\FM\16DEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74730-74731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29460]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day comment request; Generic
Clearance for Satisfaction Surveys of Customers (CSR)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH) has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection
[[Page 74731]]
listed below. This proposed information collection was previously
published in the Federal Register on August 21, 2014, page 49523 and
allowed 60 days for public comment. No public comments were received.
The purpose of this notice is to request an additional 30 days for
public comment and reinstatement without change. The Center for
Scientific Review (CSR), National Institutes of Health, may not conduct
or sponsor, and the respondent is not required to respond to, an
information collection that has been extended, revised, or implemented
on or after October 31, 2014, unless it displays a currently valid OMB
control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
DATES: Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project contact: Dr. Mary Ann
Guadagno, Project Clearance Liaison, Center for Scientific Review, NIH,
Room 3182, 6701 Rockledge Drive, Bethesda, MD 20892, or call non-toll-
free number (301) 435-1251 or Email your request, including your
address to: guadagma@csr.nih.gov. Formal requests for additional plans
and instruments must be requested in writing.
Proposed Collection: Generic Clearance for Satisfaction Surveys of
Customers (CSR), 0925-0474 expired October 31, 2014-reinstatement
without change, Center for Scientific Review (CSR), National Institutes
of Health (NIH).
Need and Use of Information Collection: The information collected
in these surveys will be used by the Center for Scientific Review
management and personnel: (1) To assess the quality of the modified
operations and processes now used by CSR to review grant applications;
(2) to assess the quality of service provided by CSR to our customers;
(3) to enable identification of the most promising biomedical research
that will have the greatest impact on improving public health by using
a peer review process that is fair unbiased from outside influence,
timely; and (4) to develop new modes of operation based on customer
need and customer feedback about the efficacy of implemented
modifications. These surveys will almost certainly lead to quality
improvement activities to enhance and/or streamline CSR's operations.
The major mechanism by which CSR will request input is through surveys.
The major initiatives ongoing at the present time include: Evaluation
of the peer review process, surveys of new and early stage
investigators, satisfaction with study section meetings using
alternative review platforms, quick feedback for peer review,
satisfaction with new reviewer orientation sessions, teleworker space
needs, improving study section alignment to ensure the best reviews,
and others. Surveys will be collected via Internet or in focus groups.
Information gathered from these surveys will be presented to, and used
directly by, CSR management to enhance the operations, processes,
organization of, and services provided by the Center.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 4323.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
A....................... Adult scientific 7925 1 30/60 3963
professionals (via
Mail/Telephone/
Internet).
B....................... Adult scientific 240 1 90/60 360
professionals (via
focus groups).
----------------------------------------------------------------------------------------------------------------
Dated: December 10, 2014.
Mary Ann Guadagno,
Project Clearance Liaison, Center for Scientific Review, National
Institutes of Health.
[FR Doc. 2014-29460 Filed 12-15-14; 8:45 am]
BILLING CODE 4140-01-P
