80 FR 10126 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 37 (February 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 37 (February 25, 2015)
| Page Range | 10126-10127 | |
| FR Document | 2015-03846 |
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)] [Notices] [Pages 10126-10127] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03846] ----------------------------------------------------------------------- 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 [[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: [email protected]. 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: 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
![10126 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices
FOR FURTHER INFORMATION CONTACT: financing and stability, mechanisms to DEPARTMENT OF HEALTH AND
Thomas P. Gross, Center for Devices and support the appropriate use of data, and HUMAN SERVICES
Radiological Health, Food and Drug policies to ensure system transparency.
Administration, 10903 New Hampshire The Planning Board was also asked to Food and Drug Administration
Ave., Bldg. 66, Rm. 2316, Silver Spring, provide recommendations about how to [Docket No. FDA–2014–N–2295]
MD 20993–0002, 301–796–5700, email: leverage the system to meet the needs of
Thomas.Gross@fda.hhs.gov. other medical device stakeholders and Request for Information on Specific
SUPPLEMENTARY INFORMATION: groups seeking to develop better Areas of Public Health Concern
evidence (http://www.brookings.edu/ Related to Racial/Ethnic Demographic
I. Background
about/centers/health/call-for- Subgroups for Additional Research by
FDA’s Center for Devices and the Office of Minority Health
Radiological Health is responsible for nominations and https://dcri.org/
protecting the public health by assuring events/past-meetings/MDEpiNet- AGENCY: Food and Drug Administration,
the safety and effectiveness of medical nominations). HHS.
devices. A key part of this mission is to This notice announces the availability ACTION: Notice; request for information.
monitor medical devices for continued and Web site location of the Planning
SUMMARY: The Food and Drug
safety and effectiveness after they are in Board’s report entitled ‘‘Strengthening Administration (FDA or the Agency) is
use and to help the public get the Patient Care: Building an Effective opening a docket to obtain information
accurate, science-based information National Medical Device Surveillance and comments on specific areas of
they need to improve their health. System.’’ FDA invites interested persons
In September 2012, the FDA public health concern for racial/ethnic
to submit comments on this report. We demographic subgroup populations,
published a report, ‘‘Strengthening Our have established a docket where
National System for Medical Device focusing on certain disease areas where
comments may be submitted (see significant outcome differences may be
Postmarket Surveillance,’’ that proposed
ADDRESSES). We believe this docket is anticipated. The Agency is seeking
a strategy for improving the current
system for monitoring medical device an important tool for receiving feedback public input on identifying areas that
safety and effectiveness. In April 2013, on this report from interested parties can be addressed through regulatory
the FDA issued an update to the and for sharing this information with science research.
September 2012 report that incorporated the public. The report ‘‘Strengthening DATES: Submit either electronic or
public input received and described the Patient Care: Building an Effective written comments or information by
next steps towards fulfilling the vision National Medical Device Surveillance April 27, 2015.
for building a national postmarket System’’ can be found at FDA’s Web site ADDRESSES: You may submit comments
surveillance system. These reports can http://www.fda.gov/AboutFDA/ by any of the following methods:
be found at FDA’s Web site http:// CentersOffices/ Electronic Submissions: Submit
www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/ electronic comments in the following
OfficeofMedicalProductsandTobacco/ CDRH/CDRHReports/ucm301912.htm. way:
CDRH/CDRHReports/ucm301912.htm. • Federal eRulemaking Portal: http://
One of these next steps consisted of II. Request for Comments www.regulations.gov. Follow the
establishing a multistakeholder instructions for submitting comments.
Interested persons may submit either Written Submissions: Submit written
planning board to identify the
electronic comments regarding this submissions in the following ways:
governance structure, practices,
policies, procedures, methodological document to http://www.regulations.gov • Mail/Hand delivery/Courier (for
approaches, and business model(s) or written comments to the Division of paper submissions): Division of Dockets
necessary to facilitate the creation of a Dockets Management (see ADDRESSES). It Management (HFA–305), Food and Drug
sustainable, integrated medical device is only necessary to send one set of Administration, 5630 Fishers Lane, Rm.
postmarket surveillance system that comments. Identify comments with the 1061, Rockville, MD 20852.
leverages and complements existing and docket number found in brackets in the Instructions: All submissions received
ongoing efforts. Under a cooperative heading of this document. Received must include the Docket No. FDA–
agreement with the FDA, the Engelberg comments may be seen in the Division 2014–N–2295 for this rulemaking. All
Center for Health Care Reform at the of Dockets Management between 9 a.m. comments received may be posted
Brookings Institution convened the and 4 p.m., Monday through Friday, and without change to http://
National Medical Device Postmarket will be posted to the docket at http:// www.regulations.gov, including any
Surveillance Planning Board (the www.regulations.gov. personal information provided. For
Planning Board) in 2014. The Planning additional information on submitting
Dated: February 20, 2015. comments, see the ‘‘Comments’’ heading
Board membership included
representatives from a broad array of Leslie Kux, of the SUPPLEMENTARY INFORMATION
stakeholder groups and areas of Associate Commissioner for Policy. section of this document.
expertise including patients, provider [FR Doc. 2015–03886 Filed 2–24–15; 8:45 am] Docket: For access to the docket to
organizations, hospitals, health plans, BILLING CODE 4164–01–P
read background documents or
industry, and government agencies, as comments received, go to http://
well as methodologists and academic www.regulations.gov and insert the
asabaliauskas on DSK5VPTVN1PROD with NOTICES
researchers. docket number(s), found in brackets in
The Planning Board was tasked with the heading of this document, into the
developing a set of long-term principles ‘‘Search’’ box and follow the prompts
and priorities for a National Postmarket and/or go to the Division of Dockets
Surveillance System. The task included Management, 5630 Fishers Lane, Rm.
identifying potential governance and 1061, Rockville, MD 20852.
business models that address legal and FOR FURTHER INFORMATION CONTACT:
privacy considerations, system Christine Merenda, Food and Drug
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![Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10127
Administration, Office of Minority ethnic demographic subgroups, to III. Comments
Health, 10903 New Hampshire Ave., inform healthcare decisions by Interested persons may submit either
Bldg. 32, Rm. 2382, Silver Spring, MD providers and patients. electronic comments regarding this
20993, 301–796–8453, FAX: 301–847– document to http://www.regulations.gov
II. Request for Comments and
8601, email: Christine.merenda@ Information or written comments to the Division of
fda.hhs.gov. Dockets Management (see ADDRESSES). It
OMH seeks comments and
SUPPLEMENTARY INFORMATION: is only necessary to send one set of
information to identify specific areas of
comments. Identify comments with the
I. Background public health concern involving racial/
docket number found in brackets in the
ethnic demographic subgroups that can
FDA’s Office of Minority Health heading of this document. Received
be addressed through regulatory science
(OMH) was established in 2010, as comments may be seen in the Division
research, including new or emerging
mandated by the Patient Protection and of Dockets Management between 9 a.m.
areas of concern. We encourage
Affordable Care Act (Pub. L. 111–148). and 4 p.m., Monday through Friday, and
comments to include supporting
OMH serves as the principal advisor to will be posted to the docket at http://
information regarding the topic
the Commissioner on minority health www.regulations.gov.
addressed, such as previously published
and health disparities. OMH provides peer-reviewed literature or new research Dated: February 19, 2015.
leadership and direction in identifying findings. These comments and Leslie Kux,
Agency actions that can help reduce information will support OMH in its Associate Commissioner for Policy.
health disparities, including the development of a research agenda that [FR Doc. 2015–03846 Filed 2–24–15; 8:45 am]
coordination of efforts across the will inform funding decisions for the BILLING CODE 4164–01–P
Agency. next fiscal year. (This notice is not a
OMH advances FDA’s regulatory
request for specific research or grant
mission in addressing the reduction of DEPARTMENT OF HEALTH AND
proposals from outside entities.) In
racial and ethnic health disparities and HUMAN SERVICES
addition to input on improving clinical
in achieving the highest standard of
trial inclusion and outcome analysis,
health for all. To achieve this mission, National Institutes of Health
requested comments and information
OMH has committed to identifying gaps
identifying disease areas with outcome
in existing knowledge to shape further Submission for OMB Review; 30-Day
differences for further study may
research projects intended to lead to Comment Request Division of Cancer
include, but are not limited to, the
better understanding of medical product Epidemiology and Genetics (DCEG)
following:
clinical outcomes in racial/ethnic Fellowship Program and Summer
• An area of study that could lead to
demographic subgroups. A guiding Student Applications (NCI)
a diagnostic or screening test based on
principle for FDA in meeting the health the development and evaluation of SUMMARY: Under the provisions of
needs of patients across the biomarkers for a disease or condition Section 3507(a)(1)(D) of the Paperwork
demographic spectrum is the that disproportionately impacts racial/ Reduction Act of 1995, the National
importance of encouraging diversity in ethnic demographic subgroups. Institutes of Health (NIH), has submitted
clinical trials. Thus, FDA is also • An area of study that could lead to to the Office of Management and Budget
interested in gaining input for changes in labeled indications, or (OMB) a request for review and
improving clinical trials in therapeutic dosages, for a single or class of drug(s) approval of the information collection
areas impacted by low rates of inclusion or biologic(s) used to treat a disease or listed below. This proposed information
of racial/ethnic demographic subgroup condition that disproportionately collection was previously published in
populations, ranging from issues impacts racial/ethnic demographic the Federal Register on April 9, 2014
surrounding recruitment and subgroups. (Vol. 79, P. 19632) and allowed 60-days
participation in clinical trials to clinical • An area of study that could lead to for public comment. No public
outcome analysis of demographic changes in the design or use of a device comments were received. The purpose
subgroup populations. Of particular to treat a disease or condition that of this notice is to allow an additional
note in this regard is FDA’s ‘‘Action disproportionately impacts racial/ethnic 30 days for public comment. The
Plan to Enhance the Collection and demographic subgroups. National Cancer Institute (NCI),
Availability of Demographic Subgroup • Research to identify effective ways National Institutes of Health, may not
Data’’ at http://www.fda.gov/downloads/ to communicate with patients and conduct or sponsor, and the respondent
RegulatoryInformation/Legislation/ consumers from racial/ethnic is not required to respond to, an
FederalFoodDrugand subgroups, including those with low information collection that has been
CosmeticActFDCAct/Significant health literacy and limited English extended, revised, or implemented on or
AmendmentstotheFDCAct/FDASIA/ proficiency, so they are informed about after October 1, 1995, unless it displays
UCM410474.pdf. FDA actions (new approvals, warnings, a currently valid OMB control number.
Research in regulatory science is recalls, etc.) that impact their health. Direct Comments to OMB: Written
distinctive for developing new tools, • Research evaluating methods to comments and/or suggestions regarding
standards, and approaches for assessing accommodate cultural and language the item(s) contained in this notice,
the safety, efficacy, quality, and differences that can improve health especially regarding the estimated
performance of all FDA-regulated communications to racial/ethnic
asabaliauskas on DSK5VPTVN1PROD with NOTICES
public burden and associated response
products. The results can help to subgroups, and assess the cost of these time, should be directed to the: Office
transform the way medical products are methods to the Government. of Management and Budget, Office of
developed, evaluated, and • Research evaluating the impact of Regulatory Affairs, OIRA_submission@
manufactured. Health disparities different formats and amounts of omb.eop.gov or by fax to 202–395–6974,
research with a regulatory focus seeks to numerical information in FDA Attention: NIH Desk Officer.
expand and strengthen knowledge of, communications for patients, health Comment Due Date: Comments
and the availability of data on, medical care providers, health educators, and regarding this information collection are
product clinical outcomes in racial/ informal caregivers. best assured of having their full effect if
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Document Created: 2015-12-18 13:09:12
Document Modified: 2015-12-18 13:09:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; request for information. | |
| Dates | Submit either electronic or written comments or information by April 27, 2015. | |
| Contact | Christine Merenda, Food and Drug 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: [email protected] | |
| FR Citation | 80 FR 10126 |
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