80 FR 14139 - Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 52 (March 18, 2015)

Page Range		14139-14140
FR Document		2015-06130

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 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.

Federal Register, Volume 80 Issue 52 (Wednesday, March 18, 2015)

[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Pages 14139-14140]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06130]


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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, [email protected], 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

Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14139

when appropriate, and other forms of mitigation strategies, and support real- data collection effort and makes the
information technology. time decision-making by the specific data request. After the initial
Department of Health and Human call, one or more additional follow-up
Emergency Shortages Data Collection
Services during actual emergencies or calls and/or electronic mail
System—Section 903(d)(2) of the
emergency preparedness exercises. correspondence may be required to
Federal Food, Drug, and Cosmetic Act
FDA developed ‘‘The Emergency verify/validate data sent from the
(OMB Control Number 0910–0491)—
Medical Device Shortages Program manufacturer, confirm receipt, and/or
(Extension)
Survey’’ in 2002 to support the request additional detail. Although the
Under section 903(d)(2) of the Federal acquisition of such data from medical regulatory officer is the agent who the
Food, Drug, and Cosmetic Act (the device manufacturers. In 2004, CDRH EST member initially contacts,
FD&C Act) (21 U.S.C. 393(d)(2)), the changed the process for the data regulatory officers may designate an
Commissioner of Food and Drugs is collection, and the electronic database alternate representative within their
authorized to implement general powers in which the data were stored was organization to correspond subsequently
(including conducting research) to carry formally renamed the ‘‘Emergency with the CDRH EST member who is
out effectively the mission of FDA. Shortages Data Collection System’’ collecting or verifying/validating the
Subsequent to the events of September (ESDCS). Recognizing that some of the data.
11, 2001, and as part of broader data collected may be commercially Because of the dynamic nature of the
counterterrorism and emergency confidential, access to the ESDCS is medical device industry, particularly
preparedness activities, FDA’s Center restricted to members of the CDRH with respect to specific product lines,
for Devices and Radiological Health Emergency Shortage Team (EST) and manufacturing capabilities, and raw
(CDRH) began developing operational senior management with a need-to- material/subcomponent sourcing, it is
plans and interventions that would know. At this time, the need-to-know necessary to update the data in the
enable CDRH to anticipate and respond senior management personnel are ESDCS at regular intervals. The EST
to medical device shortages that might limited to two senior managers. Further, makes such updates on a regular basis,
arise in the context of Federally the data are used by this defined group but makes efforts to limit the frequency
declared disasters/emergencies or only for decision making and planning of outreach to a specific manufacturer to
regulatory actions. In particular, CDRH in the context of a Federally declared no more than every 4 months.
identified the need to acquire and disaster/emergency, an official The ESDCS will only include those
maintain detailed data on domestic emergency preparedness exercise, or a medical devices for which there will
inventory, manufacturing capabilities, potential public health risk posed by likely be high demand during a specific
distribution plans, and raw material non-disaster-related device shortage. emergency/disaster, or for which there
constraints for medical devices that The data procurement process are sufficiently small numbers of
would be in high demand, and/or would consists of an initial scripted telephone manufacturers such that disruption of
be vulnerable to shortages in specific call to a regulatory officer at a registered manufacture or loss of one or more of
disaster/emergency situations or manufacturer of one or more key these manufacturers would create a
following specific regulatory actions. medical devices tracked in the ESDCS. shortage.
Such data could support prospective In this initial call, the EST member FDA estimates the burden of this
risk assessment, help inform risk describes the intent and goals of the collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of responses Total annual burden per
Activity/FD&C act section Total hours
respondents per responses response
respondent (hours)

Emergency Shortages Data Collection System (903(d)(2)) .................... 125 3 375 0.5 188
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA based the burden estimates in request will not exceed 30 minutes per DEPARTMENT OF HEALTH AND
table 1 of this document on past request cycle. HUMAN SERVICES
experience with direct contact with the Dated: March 12, 2015.
medical device manufacturers and Food and Drug Administration
Leslie Kux,
anticipated changes in the medical
device manufacturing patterns for the Associate Commissioner for Policy. [Docket No. FDA–2015–N–0001]
specific devices being monitored. FDA [FR Doc. 2015–06118 Filed 3–17–15; 8:45 am]
estimates that approximately 125 BILLING CODE 4164–01–P
Cardiovascular and Renal Drugs
manufacturers would be contacted by Advisory Committee; Amendment of
Notice
telephone and/or electronic mail 3 times
per year either to obtain primary data or AGENCY: Food and Drug Administration,
mstockstill on DSK4VPTVN1PROD with NOTICES

to verify/validate data. Because the HHS.
requested data represent data elements ACTION: Notice.
that are monitored or tracked by
manufacturers as part of routine SUMMARY: The Food and Drug
inventory management activities, it is Administration (FDA) is announcing an
anticipated that for most manufacturers, amendment to the notice of meeting of
the estimated time required of the Cardiovascular and Renal Drugs
manufacturers to complete the data Advisory Committee. This meeting was

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14140 Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices

announced in the Federal Register of DEPARTMENT OF HEALTH AND Health Statistics (NCHS), Centers for
February 27, 2015 (80 FR 10700). The HUMAN SERVICES Disease Control and Prevention (CDC).
amendment is being made to reflect a Background and Brief Description
change in the Agenda portion of the Centers for Disease Control and
document. There are no other changes. Prevention Cardiovascular disease is a leading
cause of death and disability for men
FOR FURTHER INFORMATION CONTACT: [30Day–15–14AI0] and women in the United States, among
Kristina Toliver, Center for Drug the most costly health problems facing
Evaluation and Research, Food and Agency Forms Undergoing Paperwork our nation today, and among the most
Drug Administration, 10903 New Reduction Act Review preventable. Risk factors for
Hampshire Ave., Bldg. 31, Rm. 2417, cardiovascular disease include high
The Centers for Disease Control and blood pressure and high cholesterol.
Silver Spring, MD 20993–0002, 301– Prevention (CDC) has submitted the
796–9001, FAX: 301–847–8533, Because over 50% of diabetics have
following information collection request high blood pressure, high cholesterol, or
CRDAC@fda.hhs.gov, or FDA Advisory to the Office of Management and Budget
Committee Information Line, 1–800– both conditions, the optimal systems to
(OMB) for review and approval in treat people with hypertension, high
741–8138 (301–443–0572 in the accordance with the Paperwork
Washington, DC area). Please call the cholesterol, or diabetes are interrelated.
Reduction Act of 1995. The notice for In 2005, CDC’s Division for Heart
Information Line for up-to-date the proposed information collection is Disease and Stroke Prevention (DHDSP)
information on this meeting. published to obtain comments from the began developing evaluation indicators
SUPPLEMENTARY INFORMATION: In the public and affected agencies. that reflect evidence-based outcomes
Federal Register of February 27, 2015, Written comments and suggestions from policy, systems, and
from the public and affected agencies environmental changes related to heart
FDA announced that a meeting of the
concerning the proposed collection of disease and stroke prevention. However,
Cardiovascular and Renal Drugs
information are encouraged. Your many of the indicators for short-term
Advisory Committee would be held on
comments should address any of the policy and systems changes do not have
April 15, 2015. On page 10700, in the following: (a) Evaluate whether the
first column, the Agenda portion of the readily available data sources. This is
proposed collection of information is particularly true for outcomes related to
document is changed to read as follows: necessary for the proper performance of health care systems changes.
The committee will discuss the new the functions of the agency, including NCHS proposes to conduct a new
drug application (NDA) 204958, whether the information will have information collection, the NSPCP. The
cangrelor injection, submitted by The practical utility; (b) Evaluate the survey will target primary care
Medicines Company, for the proposed accuracy of the agencies estimate of the physicians specializing in internal
indication of reduction of thrombotic burden of the proposed collection of medicine or family practice.
cardiovascular events in patients with information, including the validity of Respondents will be drawn from a
coronary artery disease (CAD) the methodology and assumptions used; nationally representative sample of
undergoing percutaneous coronary (c) Enhance the quality, utility, and physicians. Physicians working in
intervention (PCI)—(PCI refers to the clarity of the information to be hospitals, federal facilities, nursing
opening of narrowed blood vessels collected; (d) Minimize the burden of homes, rehabilitation centers and
supplying the heart muscle by a balloon the collection of information on those correctional facilities will not be eligible
inserted through an artery puncture who are to respond, including through for the survey. Eligibility will be
the use of appropriate automated, determined by phone.
with or without a stent) who have not
electronic, mechanical, or other The survey instrument will undergo
received an oral P2Y12 inhibitor prior to
technological collection techniques or cognitive testing before administration.
the PCI procedure and in whom oral other forms of information technology, The telephone screener will be
therapy with P2Y12 inhibitors is not e.g., permitting electronic submission of administered to the individual who
feasible or desirable (P2Y12 is a protein responses; and (e) Assess information answers the phone at the selected
involved in blood clotting. Inhibiting collection costs. practice. We anticipate that this will
this protein is a key mechanism of To request additional information on likely be an office assistant or medical
action of cangrelor). the proposed project or to obtain a copy secretary. The primary purpose of the
This notice is issued under the of the information collection plan and screener is to ensure correct contact
Federal Advisory Committee Act (5 instruments, call (404) 639–7570 or information for the physician, so we
U.S.C. app. 2) and 21 CFR part 14, send an email to omb@cdc.gov. Written anticipate that an office assistant or
relating to the advisory committees. comments and/or suggestions regarding medical secretary will be able to answer
the items contained in this notice the screener questions in a short amount
Dated: March 12, 2015.
should be directed to the Attention: of time. We have estimated 10 minutes
Leslie Kux, CDC Desk Officer, Office of Management per response.
Associate Commissioner for Policy. and Budget, Washington, DC 20503 or Administrators of the mail-based
[FR Doc. 2015–06130 Filed 3–17–15; 8:45 am] by fax to (202) 395–5806. Written survey will collect information about
BILLING CODE 4164–01–P comments should be received within 30 physician practices’ use of evidence-
days of this notice. based systems, including
mstockstill on DSK4VPTVN1PROD with NOTICES

multidisciplinary team approaches for
Proposed Project chronic disease treatment, electronic
National Hospital Ambulatory health records (EHR) with features
Medical Care Survey (NHAMCS) appropriate for treating patients with
Supplement of Primary Care Policies for chronic disease (e.g., clinical decision
Managing Patients with High Blood supports, patient registries), and patient
Pressure, High Cholesterol, or Diabetes follow-up mechanisms. Approximately
(NSPCP)—New—National Center for 946 physicians will participate in the

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Document Created: 2018-02-21 09:39:53
Document Modified: 2018-02-21 09:39:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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, [email protected], 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.
FR Citation		80 FR 14139

80 FR 14139 - Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 52 (March 18, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration