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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Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14141 

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

Type of respondent Form name Number of 

respondents 

Number 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Physician ......................................................... Cognitive Testing Screener ............................ 25 1 5/60 

Physician ......................................................... Cognitive Testing Protocol ............................. 15 1 1.25 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

Notice of Closed Meeting 

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 

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. 

SUMMARY: 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 

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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