Proposed Collection; 60-Day Comment Request: NIMH Database of Cognitive Training and Remediation Studies (DCTRS) (NIMH), 21250-21251 [2014-08533]
Download as PDF
<![CDATA[
21250
Federal Register / Vol. 79, No. 72 / Tuesday, April 15, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
Type of respondents
Form name
General public; specifically targeting external governmental
and non-governmental organizations including non-profit
organizations, trade associations, academic and research
institutions, and the private sector.
General public; specifically targeting external governmental
and non-governmental organizations including non-profit
organizations, trade associations, academic and research
institutions, and the private sector.
Become a Partner ..................
100
1
15/60
Become a Partner Follow-Up
Questions.
100
1
30/60
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–08446 Filed 4–14–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0848]
Compliance Policy Guide Regarding
Canned Ackee, Frozen Ackee, and
Other Ackee Products—Hypoglycin A
Toxin; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of the
Compliance Policy Guide (CPG) Sec.
550.050 Canned Ackee, Frozen Ackee,
and Other Ackee Products—Hypoglycin
A Toxin. The CPG provides guidance for
FDA staff on our enforcement criteria
for canned ackee, frozen ackee, and
other ackee products that contain
hypoglycin A.
DATES: Submit either electronic or
written comments on the CPG at any
time.
SUMMARY:
Submit written requests for
single copies of the 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, or fax your request to 301–827–
3670. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
mstockstill on DSK4VPTVN1PROD with NOTICES
ADDRESSES:
VerDate Mar<15>2010
18:06 Apr 14, 2014
Jkt 232001
Submit electronic comments on the
CPG to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Yinqing Ma, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1700.
SUPPLEMENTARY INFORMATION:
(see ADDRESSES) or electronic comments
regarding the CPG to https://
www.regulations.gov. 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.
I. Background
We are announcing the availability of
CPG Sec. 550.050 Canned Ackee, Frozen
Ackee, and Other Ackee Products—
Hypoglycin A Toxin. The CPG is being
issued consistent with our good
guidance practices regulation (21 CFR
10.115). The CPG represents our current
thinking on this topic. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
In the Federal Register of November
8, 2012 (77 FR 67013), we announced
the availability of draft CPG Sec.
550.050 Canned Ackee, Frozen Ackee,
and Other Ackee Products—Hypoglycin
A Toxin and gave interested parties an
opportunity to submit comments by
January 7, 2013, for us to consider
before beginning work on the final
version of the CPG. We received one
comment that did not pertain to the
draft CPG. We are issuing the final
version of the CPG with editorial
changes, but with no substantive
changes.
The CPG announced in this notice
finalizes the draft CPG dated November
2012.
Persons with access to the Internet
may obtain the CPG from FDA’s Office
of Regulatory Affairs CPG history page
at https://www.fda.gov/ICECI/
ComplianceManuals/CompliancePolicy
GuidanceManual/default.htm or from
https://www.regulations.gov. Use the
FDA Web site listed in the previous
sentence to find the most current
version of the guidance.
II. Comments
Interested persons may submit either
written comments regarding the CPG to
the Division of Dockets Management
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
III. Electronic Access
Dated: April 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–08428 Filed 4–14–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request: NIMH Database of Cognitive
Training and Remediation Studies
(DCTRS) (NIMH)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH), will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
SUMMARY:
E:\FR\FM\15APN1.SGM
15APN1
21251
Federal Register / Vol. 79, No. 72 / Tuesday, April 15, 2014 / Notices
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Keisha Shropshire,
NIMH Project Clearance Liaison,
Science Policy and Evaluation Branch,
OSPPC, NIMH, NIH, Neuroscience
Center, 6001 Executive Boulevard, MSC
9667, Rockville Pike, Bethesda, MD
20892, or call 301–443–4335 or Email
your request, including your address to:
kshropsh@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: NIMH Database
of Cognitive Training and Remediation
Studies, 0925–New; National Institute of
Mental Health (NIMH), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The NIMH Database of
Cognitive Training and Remediation
Studies (DCTRS) is an integrated
database that includes study- and
subject-level data from studies of
cognitive remediation (CR) in
schizophrenia. DCTRS will allow NIMH
staff and interested investigators to
examine the ways in which various
patient characteristics, intervention
approaches and features, and treatment
combinations affect responses to
remediation. The DCTRS Study
Information Form and Data Submission
Agreement are necessary for the
‘‘Submitter’’ to request permission to
submit study data to the NIMH DCTRS
for general research purposes. The
primary use of this information is to
collect submitter information and study
information for inclusion in the NIMH
DCTRS database. The DCTRS data
submission agreement includes two
forms: (1) The data submission form that
includes the terms, agreement,
submitter information and certifications,
and (2) the study information form
which collects de-identified data for
each study.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
60.
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Type of
respondent
Number of
respondents
Frequency
of response
Average time
per response
(in hours)
Annual
hour burden
Data Submission Agreement ................
Principal Investigators/Physicians ........
12
1
5
60
Dated: April 7, 2014.
Keisha L Shropshire,
Project Clearance Liaison, NIMH, NIH.
research and development of the
inventions: US Patent Application
Serial No. 13/890,502, entitled, ‘‘Viral
Chemokine-antigen Fusion Proteins’’
[HHS Ref. No. E–194–2000/0–US–06]
and in US Patent Serial No. 8,258,278
and US Patent Application Serial No.13/
587,515, both entitled ‘‘Methods and
Compositions for the Treatment and
Prevention of Cancer’’ [HHS Ref. Nos.
E–271–2006/0–US–03 and E–271–2006/
0–US–04, respectively]. The patent
rights in this invention have been
assigned to the Government of the
United States of America.
The exclusive option license may be
term-limited, the prospective territory
may be worldwide, and the field of use
may be limited to:
[FR Doc. 2014–08533 Filed 4–14–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive
Option License: Immunotherapy
Vaccine for Treating Lymphoma and
Leukemia
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the National Institutes of Health,
Department of Health and Human
Services, is contemplating the grant to
University of Texas MD Anderson
Cancer Center, of an exclusive option
license to practice the inventions
embodied in the following US Patents
and US Patent Applications (and all
foreign counterparts) for the continued
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:06 Apr 14, 2014
Jkt 232001
Research, development, manufacture, and
related non-commercial use in humans for
the treatment of B-cell leukemias and B-cell
lymphoma of a chemokine-tumor antigen
fusion protein in which the chemokine is
viral Macrophage Inflammatory Protein 3
Alpha (MIP3a) and the tumor antigen is the
epitope of a malignant B-cell
immunoglobulin idiotype of an antibody
produced by a B-cell lymphoma.
Prior to the expiration or termination of
the exclusive option license, University
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
of Texas M.D. Anderson Cancer Center
will have the exclusive right to amend
the option license to include the right to
sublicense for commercialization.
Only written comments or
applications for a license (or both)
which are received by the NIH Office of
Technology Transfer on or before April
30, 2014 will be considered.
DATES:
Requests for copies of the
patent applications, inquiries,
comments, and other materials relating
to the contemplated exclusive option
license should be directed to: Yolanda
Mock Hawkins, Ph.D., M.B.A.,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5170; Facsimile: (301) 402–0220; Email:
hawkinsy@mail.nih.gov.
ADDRESSES:
This
invention concerns a cancer treatment
for B-cell lymphoma comprising a
vaccine that increases the ability of a Bcell lymphoma antigen to provoke an
immune response in the body. In
particular, the vaccine comprises a viral
chemokine fused to a tumor antigen and
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15APN1.SGM
15APN1
]]>Agencies
[Federal Register Volume 79, Number 72 (Tuesday, April 15, 2014)]
[Notices]
[Pages 21250-21251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08533]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request: NIMH Database of
Cognitive Training and Remediation Studies (DCTRS) (NIMH)
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Mental
Health (NIMH), National Institutes of Health (NIH), will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
[[Page 21251]]
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency'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 those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Keisha
Shropshire, NIMH Project Clearance Liaison, Science Policy and
Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001
Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or
call 301-443-4335 or Email your request, including your address to:
kshropsh@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: NIMH Database of Cognitive Training and
Remediation Studies, 0925-New; National Institute of Mental Health
(NIMH), National Institutes of Health (NIH).
Need and Use of Information Collection: The NIMH Database of
Cognitive Training and Remediation Studies (DCTRS) is an integrated
database that includes study- and subject-level data from studies of
cognitive remediation (CR) in schizophrenia. DCTRS will allow NIMH
staff and interested investigators to examine the ways in which various
patient characteristics, intervention approaches and features, and
treatment combinations affect responses to remediation. The DCTRS Study
Information Form and Data Submission Agreement are necessary for the
``Submitter'' to request permission to submit study data to the NIMH
DCTRS for general research purposes. The primary use of this
information is to collect submitter information and study information
for inclusion in the NIMH DCTRS database. The DCTRS data submission
agreement includes two forms: (1) The data submission form that
includes the terms, agreement, submitter information and
certifications, and (2) the study information form which collects de-
identified data for each study.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 60.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average time
Form Type of respondent Number of Frequency of per response Annual hour
respondents response (in hours) burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Submission Agreement...................... Principal Investigators/Physicians..... 12 1 5 60
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: April 7, 2014.
Keisha L Shropshire,
Project Clearance Liaison, NIMH, NIH.
[FR Doc. 2014-08533 Filed 4-14-14; 8:45 am]
BILLING CODE 4140-01-P
