Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice, 14139-14140 [2015-06130]
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14139
Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
when appropriate, and other forms of
information technology.
Emergency Shortages Data Collection
System—Section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act
(OMB Control Number 0910–0491)—
(Extension)
Under section 903(d)(2) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)), the
Commissioner of Food and Drugs is
authorized to implement general powers
(including conducting research) to carry
out effectively the mission of FDA.
Subsequent to the events of September
11, 2001, and as part of broader
counterterrorism and emergency
preparedness activities, FDA’s Center
for Devices and Radiological Health
(CDRH) began developing operational
plans and interventions that would
enable CDRH to anticipate and respond
to medical device shortages that might
arise in the context of Federally
declared disasters/emergencies or
regulatory actions. In particular, CDRH
identified the need to acquire and
maintain detailed data on domestic
inventory, manufacturing capabilities,
distribution plans, and raw material
constraints for medical devices that
would be in high demand, and/or would
be vulnerable to shortages in specific
disaster/emergency situations or
following specific regulatory actions.
Such data could support prospective
risk assessment, help inform risk
mitigation strategies, and support realtime decision-making by the
Department of Health and Human
Services during actual emergencies or
emergency preparedness exercises.
FDA developed ‘‘The Emergency
Medical Device Shortages Program
Survey’’ in 2002 to support the
acquisition of such data from medical
device manufacturers. In 2004, CDRH
changed the process for the data
collection, and the electronic database
in which the data were stored was
formally renamed the ‘‘Emergency
Shortages Data Collection System’’
(ESDCS). Recognizing that some of the
data collected may be commercially
confidential, access to the ESDCS is
restricted to members of the CDRH
Emergency Shortage Team (EST) and
senior management with a need-toknow. At this time, the need-to-know
senior management personnel are
limited to two senior managers. Further,
the data are used by this defined group
only for decision making and planning
in the context of a Federally declared
disaster/emergency, an official
emergency preparedness exercise, or a
potential public health risk posed by
non-disaster-related device shortage.
The data procurement process
consists of an initial scripted telephone
call to a regulatory officer at a registered
manufacturer of one or more key
medical devices tracked in the ESDCS.
In this initial call, the EST member
describes the intent and goals of the
data collection effort and makes the
specific data request. After the initial
call, one or more additional follow-up
calls and/or electronic mail
correspondence may be required to
verify/validate data sent from the
manufacturer, confirm receipt, and/or
request additional detail. Although the
regulatory officer is the agent who the
EST member initially contacts,
regulatory officers may designate an
alternate representative within their
organization to correspond subsequently
with the CDRH EST member who is
collecting or verifying/validating the
data.
Because of the dynamic nature of the
medical device industry, particularly
with respect to specific product lines,
manufacturing capabilities, and raw
material/subcomponent sourcing, it is
necessary to update the data in the
ESDCS at regular intervals. The EST
makes such updates on a regular basis,
but makes efforts to limit the frequency
of outreach to a specific manufacturer to
no more than every 4 months.
The ESDCS will only include those
medical devices for which there will
likely be high demand during a specific
emergency/disaster, or for which there
are sufficiently small numbers of
manufacturers such that disruption of
manufacture or loss of one or more of
these manufacturers would create a
shortage.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/FD&C act section
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
(hours)
Total hours
Emergency Shortages Data Collection System (903(d)(2)) ....................
125
3
375
0.5
188
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA based the burden estimates in
table 1 of this document on past
experience with direct contact with the
medical device manufacturers and
anticipated changes in the medical
device manufacturing patterns for the
specific devices being monitored. FDA
estimates that approximately 125
manufacturers would be contacted by
telephone and/or electronic mail 3 times
per year either to obtain primary data or
to verify/validate data. Because the
requested data represent data elements
that are monitored or tracked by
manufacturers as part of routine
inventory management activities, it is
anticipated that for most manufacturers,
the estimated time required of
manufacturers to complete the data
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request will not exceed 30 minutes per
request cycle.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2015–06118 Filed 3–17–15; 8:45 am]
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[Docket No. FDA–2015–N–0001]
Cardiovascular and Renal Drugs
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 Cardiovascular and Renal Drugs
Advisory Committee. This meeting was
SUMMARY:
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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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]]>Agencies
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14139-14140]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06130]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Cardiovascular and Renal Drugs Advisory Committee; Amendment of
Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Cardiovascular and Renal
Drugs Advisory Committee. This meeting was
[[Page 14140]]
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.
FOR FURTHER INFORMATION CONTACT: 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.
SUPPLEMENTARY INFORMATION: 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.
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06130 Filed 3-17-15; 8:45 am]
BILLING CODE 4164-01-P
