[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10126-10127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03846]


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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.

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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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    Written Submissions: Submit written submissions in the following 
ways:
    <bullet> 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

[[Page 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: <a href="/cdn-cgi/l/email-protection#2d6e455f445e594443480340485f4843494c6d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="d596bda7bca6a1bcbbb0fbb8b0a7b0bbb1b495b3b1b4fbbdbda6fbb2baa3">[email protected]</span></a>.

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/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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


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