10126 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Thomas P. Gross, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2316, Silver Spring, 

MD 20993–0002, 301–796–5700, email: 

Thomas.Gross@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s Center for Devices and 

Radiological Health is responsible for 

protecting the public health by assuring 

the safety and effectiveness of medical 

devices. A key part of this mission is to 

monitor medical devices for continued 

safety and effectiveness after they are in 

use and to help the public get the 

accurate, science-based information 

they need to improve their health. 

In September 2012, the FDA 

published a report, ‘‘Strengthening Our 

National System for Medical Device 

Postmarket Surveillance,’’ that proposed 

a strategy for improving the current 

system for monitoring medical device 

safety and effectiveness. In April 2013, 

the FDA issued an update to the 

September 2012 report that incorporated 

public input received and described the 

next steps towards fulfilling the vision 

for building a national postmarket 

surveillance system. These reports can 

be found at FDA’s Web site http://

www.fda.gov/AboutFDA/CentersOffices/

OfficeofMedicalProductsandTobacco/

CDRH/CDRHReports/ucm301912.htm. 

One of these next steps consisted of 

establishing a multistakeholder 

planning board to identify the 

governance structure, practices, 

policies, procedures, methodological 

approaches, and business model(s) 

necessary to facilitate the creation of a 

sustainable, integrated medical device 

postmarket surveillance system that 

leverages and complements existing and 

ongoing efforts. Under a cooperative 

agreement with the FDA, the Engelberg 

Center for Health Care Reform at the 

Brookings Institution convened the 

National Medical Device Postmarket 

Surveillance Planning Board (the 

Planning Board) in 2014. The Planning 

Board membership included 

representatives from a broad array of 

stakeholder groups and areas of 

expertise including patients, provider 

organizations, hospitals, health plans, 

industry, and government agencies, as 

well as methodologists and academic 

researchers. 

The Planning Board was tasked with 

developing a set of long-term principles 

and priorities for a National Postmarket 

Surveillance System. The task included 

identifying potential governance and 

business models that address legal and 

privacy considerations, system 

financing and stability, mechanisms to 

support the appropriate use of data, and 

policies to ensure system transparency. 

The Planning Board was also asked to 

provide recommendations about how to 

leverage the system to meet the needs of 

other medical device stakeholders and 

groups seeking to develop better 

evidence (http://www.brookings.edu/

about/centers/health/call-fornominations and https://dcri.org/

events/past-meetings/MDEpiNetnominations). 

This notice announces the availability 

and Web site location of the Planning 

Board’s report entitled ‘‘Strengthening 

Patient Care: Building an Effective 

National Medical Device Surveillance 

System.’’ FDA invites interested persons 

to submit comments on this report. We 

have established a docket where 

comments may be submitted (see 

ADDRESSES). We believe this docket is 

an important tool for receiving feedback 

on this report from interested parties 

and for sharing this information with 

the public. The report ‘‘Strengthening 

Patient Care: Building an Effective 

National Medical Device Surveillance 

System’’ can be found at FDA’s Web site 

http://www.fda.gov/AboutFDA/

CentersOffices/

OfficeofMedicalProductsandTobacco/

CDRH/CDRHReports/ucm301912.htm. 

II. Request for 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 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03886 Filed 2–24–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–2295] 

Request for Information on Specific 

Areas of Public Health Concern 

Related to Racial/Ethnic Demographic 

Subgroups for Additional Research by 

the Office of Minority Health 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

opening a docket to obtain information 

and comments on specific areas of 

public health concern for racial/ethnic 

demographic subgroup populations, 

focusing on certain disease areas where 

significant outcome differences may be 

anticipated. The Agency is seeking 

public input on identifying areas that 

can be addressed through regulatory 

science research. 

DATES: Submit either electronic or 

written comments or information by 

April 27, 2015. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions: Submit 

electronic comments in the following 

way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions: Submit written 

submissions in the following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2014–N–2295 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Christine Merenda, Food and Drug 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
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