Submission for OMB Review; 30-Day Comment Request Food and Drug Administration (FDA) and the National Cancer Institute (NCI) Health Communication Survey (FDA-NCI), 54730-54731 [2014-21783]
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54730
Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Notices
believes were discontinued prior to
November 2010, were listed in the
notice.
TABLE 1—PROPOXYPHENE DRUG PRODUCT APPLICATIONS FOR WHICH FDA PROPOSED TO WITHDRAW APPROVAL
Application No.
Drug
Applicant or holder
ANDA 083544 ....
Kesso-Gesic (propoxyphene hydrochloride (HCl)) Capsules,
65 milligrams (mg).
Propoxyphene HCl Capsules, 65 mg ......................................
Compound 65 (aspirin, caffeine, and propoxyphene HCl)
Capsules, 389 mg/32.4 mg/65 mg.
MK Laboratories Inc., 424 Grasmere Ave., Fairfield, CT
06430.
Whiteworth Towne Paulsen Inc.
Alra Labs, 3850 Clearview Ct., Gurnee, IL 60031.
ANDA 084551 ....
ANDA 084553 ....
In its March 10, 2014, notice of
opportunity for a hearing, CDER
provided these ANDA holders an
opportunity to request a hearing to show
why approval of the ANDAs should not
be withdrawn. No timely request for a
hearing on this matter was received
following publication of the notice in
the Federal Register.
Therefore, under section 505(e) of the
FD&C Act and under authority
delegated to the Director of CDER by the
Commissioner of Food and Drugs,
approval of the applications listed in
table 1 and all amendments and
supplements thereto is withdrawn (see
DATES). Introduction or delivery for
introduction of these products into
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 331(d))).
Dated: September 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21729 Filed 9–11–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. This
meeting was announced in the Federal
Register of April 25, 2014 (79 FR
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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22995). The amendment is being made
to reflect a change in the Agenda
portion of the document. There are no
other changes.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Submission for OMB Review; 30-Day
Comment Request Food and Drug
Administration (FDA) and the National
Cancer Institute (NCI) Health
Communication Survey (FDA–NCI)
Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
PDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
In the
Federal Register of April 25, 2014, FDA
announced that a meeting of the Joint
Meeting of the Psychopharmacologic
Drugs Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee would be held on October
16, 2014. On page 22996, in the first
column, the Agenda portion of the
document is changed to read as follows:
Agenda: The committees will discuss
safety data from observational studies
and a meta-analysis of randomized
controlled clinical trials that have been
conducted since the original signal of
serious neuropsychiatric adverse events
with CHANTIX (varenicline tartrate
tablets, NDA 21928, Pfizer, Inc.)
emerged. The committees will also
discuss whether any action needs to be
taken with regard to how this risk is
described in product labeling.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
SUPPLEMENTARY INFORMATION:
Dated: September 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–21780 Filed 9–11–14; 8:45 am]
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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
listed below. This proposed information
collection was previously published in
the Federal Register on May 8, 2014,
Vol. 79, No. 89, page 26439 and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
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 1, 1995, 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 or request more
information on the proposed project
contact: Bradford W. Hesse, Ph.D.,
Health Communication and Informatics
Research Branch, 9609 Medical Center
SUMMARY:
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Federal Register / Vol. 79, No. 177 / Friday, September 12, 2014 / Notices
Drive, MSC 9761, Room 3E610,
Rockville, MD 20850 or call non-toll
free number 240–276–6721 or Email
your request, including your address, to
hesseb@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: Food and Drug
Administration (FDA) and the National
Cancer Institute (NCI) Health
Communication Survey (FDA–NCI),
0925–NEW, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
54731
will extend the information collected
and priorities from the Health
Information National Trends Survey
(HINTS) which has been to provide a
comprehensive assessment of the
American public’s current access to, and
use of, information about cancer across
the cancer care continuum from cancer
prevention, early detection, diagnosis,
treatment, and survivorship.
OMB approval is requested for 1 year.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 2,159.
Need and Use of Information
Collection: This partnership between
NCI and FDA will include assessing the
public’s knowledge of medical devices,
communications related to product
recalls, nutritional supplement labeling,
and topics to inform FDA’s regulatory
authority over tobacco, such as risk
perceptions about new tobacco products
and labels. This NCI–FDA survey will
couple knowledge-related questions
with inquiries into the communication
channels through which understanding
is being obtained, and assessment of
FDA-regulated material. This survey
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden
hour
Individuals ........................................................................................................
4,318
1
30/60
2,159
Dated: September 8, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–21783 Filed 9–11–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Cancer
Epidemiology Descriptive Cohort
Database (NCI)
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
listed below. This proposed information
collection was previously published in
the Federal Register on June 18, 2014,
Vol. 79, page 34766 and allowed 60days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
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 1, 1995, unless it displays
a currently valid OMB control number.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:58 Sep 11, 2014
Jkt 232001
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.
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 or request more
information on the proposed project
contact: Daniela Seminara, Senior
Scientist and Cohort and Consortia
Coordination Team Lead, Epidemiology
and Genomics Research Program
(EGRP), Division of Cancer Control and
Population Sciences (DCCPS), 9609
Medical Center Drive, Rockville, Md.
20892 or call non-toll-free number 240–
276–6748 or email your request,
including your address to:
seminard@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Cancer
Epidemiology Descriptive Cohort
Database, 0925—New, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The NCI Epidemiology and
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Genomics Research Program (EGRP)
supports large-scale collaborations
across numerous cancer epidemiology
cohorts. The collaborative approach to
date has been lacking in easily
accessible, centralized, and searchable
information. To address the need for
better collaborative research and
increased transparency, EGRP will
develop a Cancer Epidemiology
Descriptive Cohort Database (CEDCD)
accessible through a public Web site.
The information collected from the
current survey will be used to populate
the CEDCD. This public Web site will
allow investigators to know what data
and specimens exist among other
cohorts. Respondents will be cohort
Principal Investigators. The data
collection forms will be sent to
participating cohort PIs annually to
update any information that has
changed so that the CEDCD Web site
will remain current. No cohort
participant-level data is being collected
from any of the cohorts.
The information to be collected will
be aggregate descriptive information and
protocols. Though the CEDCD has a
biospecimen component (similar to the
Specimen Resource Locator), the
CEDCD is not a biospecimen locator
database. It is a database focusing
exclusively on descriptive data
pertaining to large, prospective
epidemiology cohorts.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
550.
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]]>Agencies
[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Pages 54730-54731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21783]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Food and Drug
Administration (FDA) and the National Cancer Institute (NCI) Health
Communication Survey (FDA-NCI)
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 listed below. This
proposed information collection was previously published in the Federal
Register on May 8, 2014, Vol. 79, No. 89, page 26439 and allowed 60-
days for public comment. No public comments were received. The purpose
of this notice is to allow an additional 30 days for public comment.
The National Cancer Institute (NCI), 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 1, 1995, 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, OIRAsubmission@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 or request more information on the
proposed project contact: Bradford W. Hesse, Ph.D., Health
Communication and Informatics Research Branch, 9609 Medical Center
[[Page 54731]]
Drive, MSC 9761, Room 3E610, Rockville, MD 20850 or call non-toll free
number 240-276-6721 or Email your request, including your address, to
hesseb@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: Food and Drug Administration (FDA) and the
National Cancer Institute (NCI) Health Communication Survey (FDA-NCI),
0925-NEW, National Cancer Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information Collection: This partnership between
NCI and FDA will include assessing the public's knowledge of medical
devices, communications related to product recalls, nutritional
supplement labeling, and topics to inform FDA's regulatory authority
over tobacco, such as risk perceptions about new tobacco products and
labels. This NCI-FDA survey will couple knowledge-related questions
with inquiries into the communication channels through which
understanding is being obtained, and assessment of FDA-regulated
material. This survey will extend the information collected and
priorities from the Health Information National Trends Survey (HINTS)
which has been to provide a comprehensive assessment of the American
public's current access to, and use of, information about cancer across
the cancer care continuum from cancer prevention, early detection,
diagnosis, treatment, and survivorship.
OMB approval is requested for 1 year. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 2,159.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total annual
respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Individuals................................. 4,318 1 30/60 2,159
----------------------------------------------------------------------------------------------------------------
Dated: September 8, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-21783 Filed 9-11-14; 8:45 am]
BILLING CODE 4140-01-P
