Food and Drug Administration Safety and Innovation Act 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data; Request for Comments, 489-491 [2015-33261]

Download as PDF Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Notices Agenda The purpose of the meeting is for the GLMRC to discuss the Council’s focus for the upcoming year and consider Agency initiatives. The topics to be discussed include Council metrics & GSA EVS results, GSA EEO program, and Council subcommittee updates. Meeting Access The meeting is open to the public. The meeting will be held in Room 6044 of the General Services Administration’s Headquarters Building, 1800 F Street NW., Washington, DC 20405. This site is accessible to individuals with disabilities. In order to gain entry into the Federal building where the meeting is being held, public attendees who are Federal employees should bring their Federal employee identification cards, and members of the general public should bring their driver’s license or other government-issued identification. Availability of Materials for the Meeting Please see the GLRMC Web site: http://www.gsa.gov/portal/content/ 225831 for any materials available in advance of the meeting and for meeting minutes that will be made available after the meeting. Detailed meeting minutes will be posted within 90 days of the meeting. mstockstill on DSK4VPTVN1PROD with NOTICES Procedures for Providing Public Comments The public is invited to submit written comments for the meeting until 5:00 p.m. Eastern Time on the Monday prior to the meeting, by either of the following methods: Electronic or Paper Statements: Submit electronic statements to Ms. Paula Lucak, Designated Federal Officer, at paula.lucak@gsa.gov; or send paper statements in triplicate to Ms. Lucak at 1800 F Street NW., Suite 7003A, Washington, DC 20405. In general, public comments will be posted on the GLMRC Web site. All comments, including attachments and other supporting materials received, are part of the public record and subject to public disclosure. Any comments submitted in connection with the GLMRC meeting will be made available to the public under the provisions of the Federal Advisory Committee Act. VerDate Sep<11>2014 17:32 Jan 05, 2016 Jkt 238001 Dated: December 30, 2015. Wade Hannum, Office of Human Resources Management, OHRM Director, Office of HR Strategy and Services, Center for Talent Engagement (COE4), General Services Administration. [FR Doc. 2015–33302 Filed 1–5–16; 8:45 am] BILLING CODE 6820–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of November 23, 2015. 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: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 1643, 10903 New Hampshire Ave., Silver Spring, MD 20993, Sara.Anderson@fda.hhs.gov, 301–796– 7047, 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. SUMMARY: In the Federal Register of November 23, 2015, 80 FR 72971, FDA announced that a meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee would be held on February 19, 2016. On page 72972, in the first column, the Agenda portion of the document is changed to read as follows: The Committee will discuss, make recommendations, and vote on information regarding the premarket application (PMA) for the DIAM Spinal Stabilization System, sponsored by Medtronic Sofamor Danek USA. The DIAM Spinal Stabilization System is indicated for skeletally mature patients that have moderate low back pain (with SUPPLEMENTARY INFORMATION: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 489 or without radicular pain) with current episode lasting less than 1 year in duration secondary to lumbar degenerative disc disease (DDD) at a single symptomatic level from L2–L5. DDD is confirmed radiologically with one or more of the following factors: (1) Patients must have greater than 2 mm of decreased disc height compared to the adjacent level; (2) scarring/thickening of the ligamentum flavum, annulus fibrosis, or facet joint capsule; or (3) herniated nucleus pulposus. The DIAM device is implanted via a minimally invasive posterior approach. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. 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: December 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–33262 Filed 1–5–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–4952] Food and Drug Administration Safety and Innovation Act 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration’s (FDA or Agency) Office of Minority Health (OMH), Office of Women’s Health (OWH), the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) SUMMARY: E:\FR\FM\06JAN1.SGM 06JAN1 490 Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES are announcing a public meeting seeking feedback and recommendations from patient groups, consumer groups, regulated industry, academia, and other interested parties on FDA’s progress in implementing the ‘‘Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,’’ required under the Food and Drug Administration Safety and Innovation Act (FDASIA). DATES: The public meeting will be held on February 29, 2016, from 9 a.m. to 4 p.m. The deadline for submitting comments regarding this meeting is April 29, 2016. ADDRESSES: The public meeting will be held at FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (B & C), Silver Spring, MD 20993–0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: http:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: VerDate Sep<11>2014 17:32 Jan 05, 2016 Jkt 238001 • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–N–4952 for ‘‘FDASIA 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data; Request for Comments.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential. Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 docket number, 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. FDA will post the full agenda approximately 5 days before the meeting at: http://www.fda.gov/ ForHealthProfessionals/ LearningActivities/ucm470074.htm. FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, email: FDASIA907@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, the President signed FDASIA (Pub. L. 112–144) into law. Section 907 of FDASIA directed FDA to publish and provide to Congress a report ‘‘addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups, including sex, age, race, and ethnicity, is included in applications submitted to the Food and Drug Administration.’’ Section 907 of FDASIA also directed that 1 year after the publication of the report FDA publish and provide to Congress an action plan outlining ‘‘recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, healthcare providers, and researchers’’ and to indicate the applicability of these recommendations to the types of medical products addressed in section 907. To fulfill these directives, an FDAwide steering committee with representatives from CBER, CDER, CDRH, and the Office of the Commissioner (OC) conducted a detailed assessment of the 72 new drug, biologic, and medical device applications the Agency approved in 2011. In August 2013, FDA issued a report on the group’s findings entitled ‘‘Collection, Analysis, and Availability of Demographic Subgroup Data for FDAApproved Medical Products.’’ In August 2014, FDA followed up with a report entitled ‘‘FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,’’ which contained 27 action items divided up into three overriding priorities: Data quality, subgroup participation, and data transparency. E:\FR\FM\06JAN1.SGM 06JAN1 Federal Register / Vol. 81, No. 3 / Wednesday, January 6, 2016 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES The purpose of the public meeting is to report on FDA’s progress implementing the Action Plan, to discuss how stakeholders have been affected by these changes, and to solicit feedback and recommendations for further implementation from interested parties and stakeholders. Some questions we would like the public to comment on during the meeting include: 1. What approaches have been successful in addressing key barriers to recruiting diverse clinical trial populations? 2. What are your key limitations to conducting meaningful data analysis of underrepresented groups? 3. What have you learned about best practices for recruiting a broad representation of subjects for clinical trials? Which practices have been successful and why? Which have not and why? 4. What communication strategies have you successfully used that were also sensitive to the needs of underrepresented populations? 5. What are potential methods FDA should consider using to effectively communicate meaningful information on demographic analyses to a diverse public? 6. What are some of the actual or potential unintended consequences of data transparency you have encountered related to reporting demographic subgroup analysis? Stakeholders are invited to provide brief comments on these topics during the public comment portion of the meeting, but are not limited to discussing only the previous topics. Since the day-long meeting may not provide enough time to fully address all of these issues, we encourage interested groups to submit longer explanations and comments to the docket. II. Registration and Request for Oral Presentations FDA will try to accommodate all participant requests to speak; however, the duration of comments may be limited by time constraints. Those wishing to make oral presentations will be asked to send a brief summary of their comments and registration information (including name, title, firm name, address, telephone, email address, and fax number), and should register by February 1, 2016, by emailing FDASIA907@fda.hhs.gov. All other participants are asked to register online at: http://www.fda.gov/ ForHealthProfessionals/ LearningActivities/ucm470074.htm by February 13, 2016, whether they plan to attend in person or listen to the meeting VerDate Sep<11>2014 17:32 Jan 05, 2016 Jkt 238001 on a live Webcast. Registration is free and will be on a first-come, first-served basis. Onsite registration on the day of the meeting will be based on space availability. Information on how to access the Webcast will be posted approximately 5 days before the meeting at: http://www.fda.gov/ ForHealthProfessionals/ LearningActivities/ucm470074.htm. If you need special accommodations due to a disability, please contact FDASIA907@fda.hhs.gov at least 7 days in advance. Persons attending the public meeting are advised that FDA is not responsible for providing access to electrical outlets. Dated: December 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–33261 Filed 1–5–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 4, 2016, from 8:30 a.m. to 3 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. For those unable to attend in person, the meeting will also be Web cast and will be available at the following link https:// collaboration.fda.gov/vrbpac030416/. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/ AdvisoryCommittees/ PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 491 AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Sujata Vijh or Denise Royster, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993–0002, 240–402–7107 or 240– 402–8158, email: Sujata.vijh@ fda.hhs.gov or denise.royster@ fda.hhs.gov or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On March 4, 2016, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2016–2017 influenza season. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 19, 2016. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:40 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 10, 2016. Time allotted for each presentation may be E:\FR\FM\06JAN1.SGM 06JAN1

Agencies

[Federal Register Volume 81, Number 3 (Wednesday, January 6, 2016)]
[Notices]
[Pages 489-491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4952]


Food and Drug Administration Safety and Innovation Act 907 Public 
Meeting: Progress on Enhancing the Collection, Analysis, and 
Availability of Demographic Subgroup Data; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA or Agency) Office of 
Minority Health (OMH), Office of Women's Health (OWH), the Center for 
Biologics Evaluation and Research (CBER), the Center for Drug 
Evaluation and Research (CDER), and the Center for Devices and 
Radiological Health (CDRH)

[[Page 490]]

are announcing a public meeting seeking feedback and recommendations 
from patient groups, consumer groups, regulated industry, academia, and 
other interested parties on FDA's progress in implementing the ``Action 
Plan to Enhance the Collection and Availability of Demographic Subgroup 
Data,'' required under the Food and Drug Administration Safety and 
Innovation Act (FDASIA).

DATES: The public meeting will be held on February 29, 2016, from 9 
a.m. to 4 p.m. The deadline for submitting comments regarding this 
meeting is April 29, 2016.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room 
(B & C), Silver Spring, MD 20993-0002. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-4952 for ``FDASIA 907 Public Meeting: Progress on Enhancing 
the Collection, Analysis, and Availability of Demographic Subgroup 
Data; Request for Comments.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential. Any information marked as ``confidential'' will not be 
disclosed except in accordance with 21 CFR 10.20 and other applicable 
disclosure law. For more information about FDA's posting of comments to 
public dockets, see 80 FR 56469, September 18, 2015, or access the 
information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, 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.
    FDA will post the full agenda approximately 5 days before the 
meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.

FOR FURTHER INFORMATION CONTACT: Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, email: 
FDASIA907@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed FDASIA (Pub. L. 112-144) into 
law. Section 907 of FDASIA directed FDA to publish and provide to 
Congress a report ``addressing the extent to which clinical trial 
participation and the inclusion of safety and effectiveness data by 
demographic subgroups, including sex, age, race, and ethnicity, is 
included in applications submitted to the Food and Drug 
Administration.'' Section 907 of FDASIA also directed that 1 year after 
the publication of the report FDA publish and provide to Congress an 
action plan outlining ``recommendations for improving the completeness 
and quality of analyses of data on demographic subgroups in summaries 
of product safety and effectiveness data and in labeling; on the 
inclusion of such data, or the lack of availability of such data, in 
labeling; and on improving the public availability of such data to 
patients, healthcare providers, and researchers'' and to indicate the 
applicability of these recommendations to the types of medical products 
addressed in section 907. To fulfill these directives, an FDA-wide 
steering committee with representatives from CBER, CDER, CDRH, and the 
Office of the Commissioner (OC) conducted a detailed assessment of the 
72 new drug, biologic, and medical device applications the Agency 
approved in 2011. In August 2013, FDA issued a report on the group's 
findings entitled ``Collection, Analysis, and Availability of 
Demographic Subgroup Data for FDA-Approved Medical Products.'' In 
August 2014, FDA followed up with a report entitled ``FDA Action Plan 
to Enhance the Collection and Availability of Demographic Subgroup 
Data,'' which contained 27 action items divided up into three 
overriding priorities: Data quality, subgroup participation, and data 
transparency.

[[Page 491]]

    The purpose of the public meeting is to report on FDA's progress 
implementing the Action Plan, to discuss how stakeholders have been 
affected by these changes, and to solicit feedback and recommendations 
for further implementation from interested parties and stakeholders.
    Some questions we would like the public to comment on during the 
meeting include:
    1. What approaches have been successful in addressing key barriers 
to recruiting diverse clinical trial populations?
    2. What are your key limitations to conducting meaningful data 
analysis of underrepresented groups?
    3. What have you learned about best practices for recruiting a 
broad representation of subjects for clinical trials? Which practices 
have been successful and why? Which have not and why?
    4. What communication strategies have you successfully used that 
were also sensitive to the needs of underrepresented populations?
    5. What are potential methods FDA should consider using to 
effectively communicate meaningful information on demographic analyses 
to a diverse public?
    6. What are some of the actual or potential unintended consequences 
of data transparency you have encountered related to reporting 
demographic subgroup analysis?
    Stakeholders are invited to provide brief comments on these topics 
during the public comment portion of the meeting, but are not limited 
to discussing only the previous topics. Since the day-long meeting may 
not provide enough time to fully address all of these issues, we 
encourage interested groups to submit longer explanations and comments 
to the docket.

II. Registration and Request for Oral Presentations

    FDA will try to accommodate all participant requests to speak; 
however, the duration of comments may be limited by time constraints. 
Those wishing to make oral presentations will be asked to send a brief 
summary of their comments and registration information (including name, 
title, firm name, address, telephone, email address, and fax number), 
and should register by February 1, 2016, by emailing 
FDASIA907@fda.hhs.gov.
    All other participants are asked to register online at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm by 
February 13, 2016, whether they plan to attend in person or listen to 
the meeting on a live Webcast. Registration is free and will be on a 
first-come, first-served basis. Onsite registration on the day of the 
meeting will be based on space availability. Information on how to 
access the Webcast will be posted approximately 5 days before the 
meeting at: http://www.fda.gov/ForHealthProfessionals/LearningActivities/ucm470074.htm.
    If you need special accommodations due to a disability, please 
contact FDASIA907@fda.hhs.gov at least 7 days in advance. Persons 
attending the public meeting are advised that FDA is not responsible 
for providing access to electrical outlets.

    Dated: December 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33261 Filed 1-5-16; 8:45 am]
 BILLING CODE 4164-01-P