Agency Forms Undergoing Paperwork Reduction Act Review, 14140-14141 [2015-06159]
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14140
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
announced in the Federal Register of
February 27, 2015 (80 FR 10700). 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
Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC).
Centers for Disease Control and
Prevention
FOR FURTHER INFORMATION CONTACT:
[30Day–15–14AI0]
Background and Brief Description
Cardiovascular disease is a leading
cause of death and disability for men
and women in the United States, among
the most costly health problems facing
our nation today, and among the most
preventable. Risk factors for
cardiovascular disease include high
blood pressure and high cholesterol.
Because over 50% of diabetics have
high blood pressure, high cholesterol, or
both conditions, the optimal systems to
treat people with hypertension, high
cholesterol, or diabetes are interrelated.
In 2005, CDC’s Division for Heart
Disease and Stroke Prevention (DHDSP)
began developing evaluation indicators
that reflect evidence-based outcomes
from policy, systems, and
environmental changes related to heart
disease and stroke prevention. However,
many of the indicators for short-term
policy and systems changes do not have
readily available data sources. This is
particularly true for outcomes related to
health care systems changes.
NCHS proposes to conduct a new
information collection, the NSPCP. The
survey will target primary care
physicians specializing in internal
medicine or family practice.
Respondents will be drawn from a
nationally representative sample of
physicians. Physicians working in
hospitals, federal facilities, nursing
homes, rehabilitation centers and
correctional facilities will not be eligible
for the survey. Eligibility will be
determined by phone.
The survey instrument will undergo
cognitive testing before administration.
The telephone screener will be
administered to the individual who
answers the phone at the selected
practice. We anticipate that this will
likely be an office assistant or medical
secretary. The primary purpose of the
screener is to ensure correct contact
information for the physician, so we
anticipate that an office assistant or
medical secretary will be able to answer
the screener questions in a short amount
of time. We have estimated 10 minutes
per response.
Administrators of the mail-based
survey will collect information about
physician practices’ use of evidencebased systems, including
multidisciplinary team approaches for
chronic disease treatment, electronic
health records (EHR) with features
appropriate for treating patients with
chronic disease (e.g., clinical decision
supports, patient registries), and patient
follow-up mechanisms. Approximately
946 physicians will participate in the
Kristina Toliver, 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,
CRDAC@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 February 27, 2015,
FDA announced that a meeting of the
Cardiovascular and Renal Drugs
Advisory Committee would be held on
April 15, 2015. On page 10700, in the
first column, the Agenda portion of the
document is changed to read as follows:
The committee will discuss the new
drug application (NDA) 204958,
cangrelor injection, submitted by The
Medicines Company, for the proposed
indication of reduction of thrombotic
cardiovascular events in patients with
coronary artery disease (CAD)
undergoing percutaneous coronary
intervention (PCI)—(PCI refers to the
opening of narrowed blood vessels
supplying the heart muscle by a balloon
inserted through an artery puncture
with or without a stent) who have not
received an oral P2Y12 inhibitor prior to
the PCI procedure and in whom oral
therapy with P2Y12 inhibitors is not
feasible or desirable (P2Y12 is a protein
involved in blood clotting. Inhibiting
this protein is a key mechanism of
action of cangrelor).
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: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06130 Filed 3–17–15; 8:45 am]
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BILLING CODE 4164–01–P
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
National Hospital Ambulatory
Medical Care Survey (NHAMCS)
Supplement of Primary Care Policies for
Managing Patients with High Blood
Pressure, High Cholesterol, or Diabetes
(NSPCP)—New—National Center for
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14141
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
information collection. This is a onetime data collection effort.
CDC will use the information to
examine health systems and
dissemination of health systems
technology. Primary care practices will
use the results to inform their systems
for managing patients with chronic
conditions and to improve the quality of
care delivered. NCHS and CDC will also
use the results to improve technical
assistance to public health partners.
OMB approval is requested for two
years. Participation in the survey is
voluntary and all responses CDC will
de-identify all responses. There are no
costs to respondents other than their
time. The total estimated annualized
burden hours are 429.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
Physician .........................................................
Physician .........................................................
Medical Secretary ...........................................
Physician .........................................................
Cognitive Testing Screener ............................
Cognitive Testing Protocol .............................
NSPCP Screener ...........................................
NSPCP ...........................................................
Leroy A. 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. 2015–06159 Filed 3–17–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Closed Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIAMS.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Arthritis and
Musculoskeletal and Skin Diseases,
including consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIAMS.
Date: April 15–16, 2015.
Time: 6:00 p.m. to 3:45 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 31, Room 4C32, 31 Center Drive,
Bethesda, MD 20892.
Contact Person: John J. O’Shea, MD, Ph.D.,
Scientific Director, National Institute of
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Arthritis & Musculoskeletal and Skin
Diseases, Building 10, Room 9N228, MSC
1820, Bethesda, MD 20892, (301) 496–2612,
osheaj@arb.niams.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS).
Dated: March 12, 2015.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06122 Filed 3–17–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
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.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
SUMMARY:
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Number
responses per
respondent
25
15
1,500
473
1
1
1
1
Average
burden per
response
(in hours)
5/60
1.25
10/60
20/60
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.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
GTF2I Mutations as Genetic Marker for
Prognosis of Thymic Malignancies
Description of Technology: The
present invention describes the
presence of a mutation in the general
transcription factor IIi (GTF2I) gene in
indolent thymic tumors that is rarely
found in more aggressive thymic
tumors.
The invention provides a method of
determining the prognosis of thymic
cancer in a patient by assaying (for
example using PCR based methods) the
genetic material obtained from the
patient tissue to detect a mutation in at
least one copy of GTF2I genetic
sequence; and correlating the presence
of a GTF2I mutation with the prognosis
of a thymic cancer patient, the presence
of the mutation indicating that the
thymic cancer is indolent.
A genetic test will complement the
diagnostic assessment, facilitate
development of a molecular
classification and assessment for the
clinical management of thymic cancers.
Potential Commercial Applications:
• A diagnostic test kit for the
prognosis and clinical management of
thymic cancer.
• Clinical decision whether treatment
is needed (for example, additional
treatment after surgery).
• Therapeutic decision making,
between an aggressive course of
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]]>Agencies
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14140-14141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06159]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-14AI0]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
National Hospital Ambulatory Medical Care Survey (NHAMCS)
Supplement of Primary Care Policies for Managing Patients with High
Blood Pressure, High Cholesterol, or Diabetes (NSPCP)--New--National
Center for Health Statistics (NCHS), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Cardiovascular disease is a leading cause of death and disability
for men and women in the United States, among the most costly health
problems facing our nation today, and among the most preventable. Risk
factors for cardiovascular disease include high blood pressure and high
cholesterol. Because over 50% of diabetics have high blood pressure,
high cholesterol, or both conditions, the optimal systems to treat
people with hypertension, high cholesterol, or diabetes are
interrelated.
In 2005, CDC's Division for Heart Disease and Stroke Prevention
(DHDSP) began developing evaluation indicators that reflect evidence-
based outcomes from policy, systems, and environmental changes related
to heart disease and stroke prevention. However, many of the indicators
for short-term policy and systems changes do not have readily available
data sources. This is particularly true for outcomes related to health
care systems changes.
NCHS proposes to conduct a new information collection, the NSPCP.
The survey will target primary care physicians specializing in internal
medicine or family practice. Respondents will be drawn from a
nationally representative sample of physicians. Physicians working in
hospitals, federal facilities, nursing homes, rehabilitation centers
and correctional facilities will not be eligible for the survey.
Eligibility will be determined by phone.
The survey instrument will undergo cognitive testing before
administration.
The telephone screener will be administered to the individual who
answers the phone at the selected practice. We anticipate that this
will likely be an office assistant or medical secretary. The primary
purpose of the screener is to ensure correct contact information for
the physician, so we anticipate that an office assistant or medical
secretary will be able to answer the screener questions in a short
amount of time. We have estimated 10 minutes per response.
Administrators of the mail-based survey will collect information
about physician practices' use of evidence-based systems, including
multidisciplinary team approaches for chronic disease treatment,
electronic health records (EHR) with features appropriate for treating
patients with chronic disease (e.g., clinical decision supports,
patient registries), and patient follow-up mechanisms. Approximately
946 physicians will participate in the
[[Page 14141]]
information collection. This is a one-time data collection effort.
CDC will use the information to examine health systems and
dissemination of health systems technology. Primary care practices will
use the results to inform their systems for managing patients with
chronic conditions and to improve the quality of care delivered. NCHS
and CDC will also use the results to improve technical assistance to
public health partners.
OMB approval is requested for two years. Participation in the
survey is voluntary and all responses CDC will de-identify all
responses. There are no costs to respondents other than their time. The
total estimated annualized burden hours are 429.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Physician............................. Cognitive Testing 25 1 5/60
Screener.
Physician............................. Cognitive Testing 15 1 1.25
Protocol.
Medical Secretary..................... NSPCP Screener.......... 1,500 1 10/60
Physician............................. NSPCP................... 473 1 20/60
----------------------------------------------------------------------------------------------------------------
Leroy A. 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. 2015-06159 Filed 3-17-15; 8:45 am]
BILLING CODE 4163-18-P
