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

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 

1There 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 

request will not exceed 30 minutes per 

request cycle. 

Dated: March 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06118 Filed 3–17–15; 8:45 am] 

BILLING CODE 4164–01–P 

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 

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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. 

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 

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 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 

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