Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10127 

Administration, Office of Minority 

Health, 10903 New Hampshire Ave., 

Bldg. 32, Rm. 2382, Silver Spring, MD 

20993, 301–796–8453, FAX: 301–847– 

8601, email: Christine.merenda@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s Office of Minority Health 

(OMH) was established in 2010, as 

mandated by the Patient Protection and 

Affordable Care Act (Pub. L. 111–148). 

OMH serves as the principal advisor to 

the Commissioner on minority health 

and health disparities. OMH provides 

leadership and direction in identifying 

Agency actions that can help reduce 

health disparities, including the 

coordination of efforts across the 

Agency. 

OMH advances FDA’s regulatory 

mission in addressing the reduction of 

racial and ethnic health disparities and 

in achieving the highest standard of 

health for all. To achieve this mission, 

OMH has committed to identifying gaps 

in existing knowledge to shape further 

research projects intended to lead to 

better understanding of medical product 

clinical outcomes in racial/ethnic 

demographic subgroups. A guiding 

principle for FDA in meeting the health 

needs of patients across the 

demographic spectrum is the 

importance of encouraging diversity in 

clinical trials. Thus, FDA is also 

interested in gaining input for 

improving clinical trials in therapeutic 

areas impacted by low rates of inclusion 

of racial/ethnic demographic subgroup 

populations, ranging from issues 

surrounding recruitment and 

participation in clinical trials to clinical 

outcome analysis of demographic 

subgroup populations. Of particular 

note in this regard is FDA’s ‘‘Action 

Plan to Enhance the Collection and 

Availability of Demographic Subgroup 

Data’’ at http://www.fda.gov/downloads/ 

RegulatoryInformation/Legislation/

FederalFoodDrugand

CosmeticActFDCAct/Significant

AmendmentstotheFDCAct/FDASIA/

UCM410474.pdf. 

Research in regulatory science is 

distinctive for developing new tools, 

standards, and approaches for assessing 

the safety, efficacy, quality, and 

performance of all FDA-regulated 

products. The results can help to 

transform the way medical products are 

developed, evaluated, and 

manufactured. Health disparities 

research with a regulatory focus seeks to 

expand and strengthen knowledge of, 

and the availability of data on, medical 

product clinical outcomes in racial/

ethnic demographic subgroups, to 

inform healthcare decisions by 

providers and patients. 

II. Request for Comments and 

Information 

OMH seeks comments and 

information to identify specific areas of 

public health concern involving racial/ 

ethnic demographic subgroups that can 

be addressed through regulatory science 

research, including new or emerging 

areas of concern. We encourage 

comments to include supporting 

information regarding the topic 

addressed, such as previously published 

peer-reviewed literature or new research 

findings. These comments and 

information will support OMH in its 

development of a research agenda that 

will inform funding decisions for the 

next fiscal year. (This notice is not a 

request for specific research or grant 

proposals from outside entities.) In 

addition to input on improving clinical 

trial inclusion and outcome analysis, 

requested comments and information 

identifying disease areas with outcome 

differences for further study may 

include, but are not limited to, the 

following: 

• An area of study that could lead to 

a diagnostic or screening test based on 

the development and evaluation of 

biomarkers for a disease or condition 

that disproportionately impacts racial/

ethnic demographic subgroups. 

• An area of study that could lead to 

changes in labeled indications, or 

dosages, for a single or class of drug(s) 

or biologic(s) used to treat a disease or 

condition that disproportionately 

impacts racial/ethnic demographic 

subgroups. 

• An area of study that could lead to 

changes in the design or use of a device 

to treat a disease or condition that 

disproportionately impacts racial/ethnic 

demographic subgroups. 

• Research to identify effective ways 

to communicate with patients and 

consumers from racial/ethnic 

subgroups, including those with low 

health literacy and limited English 

proficiency, so they are informed about 

FDA actions (new approvals, warnings, 

recalls, etc.) that impact their health. 

• Research evaluating methods to 

accommodate cultural and language 

differences that can improve health 

communications to racial/ethnic 

subgroups, and assess the cost of these 

methods to the Government. 

• Research evaluating the impact of 

different formats and amounts of 

numerical information in FDA 

communications for patients, health 

care providers, health educators, and 

informal caregivers. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: February 19, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03846 Filed 2–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request Division of Cancer 

Epidemiology and Genetics (DCEG) 

Fellowship Program and Summer 

Student Applications (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on April 9, 2014 

(Vol. 79, P. 19632) and allowed 60-days 

for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. The 

National Cancer Institute (NCI), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
10128 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project 

contact: Jackie Lavigne, Office of 

Education, Division of Cancer 

Epidemiology and Genetics, 9609 

Medical Center Drive, MSC 9776, 

Bethesda, MD 20892–9776 or call nontoll-free number 240–376–7237 or Email 

your request, including your address to: 

lavignej@mail.nih.gov. Formal requests 

for additional plans and instruments 

must be requested in writing. 

Proposed Collection: Division of 

Cancer Epidemiology and Genetics 

(DCEG) Fellowship Program and 

Summer Student Applications (NCI), 

Existing Collection in Use without OMB 

Control Number, National Cancer 

Institute (NCI), National Institutes of 

Health (NIH). 

Need and Use of Information 

Collection: The Division of Cancer 

Epidemiology and Genetics (DCEG) 

Office of Education (OE) administers a 

variety of programs and initiatives to 

recruit pre-college through post-doctoral 

educational level individuals into the 

Intramural Research Program to 

facilitate their development into future 

biomedical scientists. DCEG trains postdoctoral, doctoral candidates, graduate 

and baccalaureate students, through full 

time fellowships, summer fellowships, 

and internships in preparation for 

research careers in cancer epidemiology 

and genetics. The proposed information 

collection involves brief online 

applications completed by applicants to 

the full time and the summer fellowship 

programs. Full-time fellowships 

include: Full-time Equivalents (FTE) 

and non-FTE fellowships for US 

citizens, permanent residents and 

international fellows. These 

applications are essential to the 

administration of these training 

programs as they enable OE to 

determine the eligibility and quality of 

potential awardees; to assess their 

potential as future scientists; to 

determine where mutual research 

interests exist; and to make decisions 

regarding which applicants will be 

proposed and approved for traineeship 

awards. In each case, completing the 

application is voluntary, but in order to 

receive due consideration, the 

prospective trainee is encouraged to 

complete all relevant fields. The 

information is for internal use to make 

decisions about prospective fellows and 

students that could benefit from the 

DCEG program. 

OMB approval is requested for 3 

years. There are no costs to respondents 

other than their time. The total 

estimated annualized burden hours are 

175. 

ESTIMATED ANNUALIZED BURDEN HOURS

Form name Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total annual 

burden hours 

Fellowship Program Application ................... Full-time Fellows ................... 150 1 30/60 75 

Summer Program Application ....................... Summer Students ................. 300 1 20/60 100 

Dated: February 19, 2015. 

Karla Bailey, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2015–03789 Filed 2–24–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Assessment of 

Oncology Nursing Education and 

Training in Low and Middle Income 

Countries (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on July 8, 2014, 

Vol. 79, page 38542 and allowed 60- 

days for public comment. One public 

comment was received on July 9, 2014. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Cancer Institute (NCI), 

National Institutes of Health, may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid OMB control number. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_submission@

omb.eop.gov or by fax to 202–395–6974, 

Attention: NIH Desk Officer. 

Comment Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments or request more 

information on the proposed project, 

contact: Annette Galassi, Center for 

Global Health, National Cancer Institute, 

9609 Medical Center Dr., Rm. 3W250, 

Rockville, MD 20850 or call non-tollfree number 240–276–6632 or Email 

your request, including your address to: 

agalassi@mail.nih.gov. Formal requests 

for additional plans and instruments 

must be requested in writing. 

Proposed Collection: Assessment of 

Oncology Nursing Education and 

Training in Low and Middle Income 

Countries, 0925–NEW, National Cancer 

Institute (NCI), National Institutes of 

Health (NIH). 

Need and Use of Information 

Collection: This submission is a request 

for OMB to approve the Assessment of 

Oncology Nursing Education and 

Training in Low and Middle Income 

Countries (LMICs). NCI-Designated 

Cancer Centers have a range of 

international activities, some of which 

are funded by NCI, but many of which 

are not. These international activities 

may include oncology nursing 

education and training in LMICs, but 

the extent of these activities across 

cancer centers is unknown. The 

proposed assessment requests 

information about oncology nursing 

education and training projects 

including: descriptions of projects, 

partner organizations, types of activities, 

cost, and impact. The information will 

be collected annually. NCI’s Center for 

Global Health (CGH) is in the process of 

developing its strategic plan for 

oncology nursing education in LMICs. 


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