80 FR 66909 - Clinical Trials-Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 210 (October 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66909-66910 | |
| FR Document | 2015-27728 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Notices] [Pages 66909-66910] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27728] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-3805] Clinical Trials--Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled ``Clinical Trials--Assessing Safety and Efficacy in Diverse Populations.'' The purpose of the meeting is to discuss approaches in clinical trial design and subgroup analyses for therapeutic product development and life-cycle management. DATES: The meeting will be held on December 2, 2015, from 9 a.m. to 5 p.m. ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), 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-3805 for Clinical Trials--Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments. Received [[Page 66910]] 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. FOR FURTHER INFORMATION CONTACT: Martin Mendoza, Office of Minority Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2306, Silver Spring, MD 20993-0002, [email protected]. SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to facilitate a unique opportunity for relevant stakeholders, including industry, academia, patients, and FDA, to discuss the importance of diversity in medical research and the incorporation of participant diversity in the design, analysis, and regulation of medical interventions. Medical interventions may have different benefits and harms for subgroups within a population. If clinical trials do not include an adequate number of participants who are representative of people likely to use an approved intervention, then the average results of clinical trials might not be replicated in practice. Even if clinical trials include representative participants, important subgroup differences might not be detectable if their representation is not adequate. For these reasons, regulators might use a combination of information from clinical trials and other data sources to address questions about heterogeneity across large and diverse populations. The use of data from patients in their usual care setting (``real-world'' data) may be particularly valuable for understanding this heterogeneity. Agenda: The agenda is located at: http://www.jhsph.edu/research/centers-and-institutes/center-of-excellence-in-regulatory-science-and-innovation/news-and-events/clinical-trials-assessing-safety-and-efficacy-for-diverse-population.html. (FDA has verified the Web site addresses throughout this notice, but FDA is not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register). Registration: There is no registration fee to attend this meeting. Seats are limited, and registration will be on a first-come, first- served basis. To register, please complete registration online at http://www.surveymonkey.com/r/ClinicalTrialsWorkshop120215. (FDA has verified the Web address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Accommodations: Attendees are responsible for their own hotel accommodations. If you need special accommodations due to a disability, please contact Jill Zung at [email protected] at least 7 days in advance. Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27728 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices 66909
obligation to obtain an IND for the For dietary supplements: Conference Center, the Great Room (Rm.
following types of studies evaluating the • Clinical studies designed to 1503), Silver Spring, MD 20993–0002.
effects of a product marketed as a evaluate a dietary supplement’s ability Entrance for the public meeting
conventional food or dietary to diagnose, cure, mitigate, treat, or participants (non-FDA employees) is
supplement: prevent a disease, except for studies through Building 1 where routine
For conventional foods: designed to evaluate whether a dietary security check procedures will be
• Clinical studies designed to supplement reduces the risk of a performed. For parking and security
evaluate whether a conventional food disease, intended to support a health information, please refer to http://
may reduce the risk of a disease, claim, and conducted in a population www.fda.gov/AboutFDA/
intended to support a new or expanded that does not include individuals less WorkingatFDA/BuildingsandFacilities/
health claim, and conducted in a than 12 months old, those with altered WhiteOakCampusInformation/
population that does not include immune systems, or those with serious ucm241740.htm.
individuals less than 12 months old, or life-threatening medical conditions; You may submit comments as
those with altered immune systems, or • Clinical studies designed to follows:
those with serious or life-threatening evaluate whether a dietary supplement
medical conditions; Electronic Submissions
reduces the risk of a disease, intended
• Clinical studies designed to to support a new or expanded health Submit electronic comments in the
evaluate a non-nutritional effect of a claim, and conducted in a population following way:
conventional food on the structure or that includes individuals less than 12 • Federal eRulemaking Portal: http://
function of the body. months old, those with altered immune www.regulations.gov. Follow the
For dietary supplements: systems, or those with serious or life- instructions for submitting comments.
• Clinical studies designed to threatening medical conditions. Comments submitted electronically,
evaluate whether a dietary supplement For cosmetics: including attachments, to http://
may reduce the risk of a disease, • Clinical studies designed to www.regulations.gov will be posted to
intended to support a new or expanded evaluate a cosmetic’s effect on the the docket unchanged. Because your
health claim, and conducted in a structure or function of the body or its comment will be made public, you are
population that does not include ability to diagnose, cure, mitigate, treat, solely responsible for ensuring that your
individuals less than 12 months old, or prevent a disease. comment does not include any
those with altered immune systems, or confidential information that you or a
Dated: October 26, 2015.
those with serious or life-threatening third party may not wish to be posted,
Leslie Kux,
medical conditions. such as medical information, your or
Further, as noted in the final guidance Associate Commissioner for Policy. anyone else’s Social Security number, or
itself, no IND is required for clinical [FR Doc. 2015–27729 Filed 10–29–15; 8:45 am] confidential business information, such
studies designed to evaluate the BILLING CODE 4164–01–P as a manufacturing process. Please note
nutritional effects of a conventional that if you include your name, contact
food, clinical studies designed to information, or other information that
evaluate a dietary supplement’s effects DEPARTMENT OF HEALTH AND identifies you in the body of your
on the structure or function of the body, HUMAN SERVICES comments, that information will be
or clinical studies designed to evaluate posted on http://www.regulations.gov.
Food and Drug Administration
the relationship between a conventional • If you want to submit a comment
food or dietary supplement and reduced [Docket No. FDA–2015–N–3805] with confidential information that you
risk of a disease, if there is already an do not wish to be made available to the
authorized health claim for the Clinical Trials—Assessing Safety and public, submit the comment as a
substance-disease relationship. Efficacy for Diverse Populations; written/paper submission and in the
The following types of studies do Public Meeting; Request for Comments manner detailed (see ‘‘Written/Paper
continue to require an IND for the AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
reasons explained in the final guidance: HHS.
For conventional foods: Written/Paper Submissions
• Clinical studies designed to Notice of meeting; request for
ACTION:
Submit written/paper submissions as
evaluate a conventional food’s ability to comments. follows:
diagnose, cure, mitigate, treat, or SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
prevent a disease, except for studies Administration (FDA), in collaboration written/paper submissions): Division of
designed to evaluate whether a with the Johns Hopkins Center of Dockets Management (HFA–305), Food
conventional food reduces the risk of a Excellence in Regulatory Science and and Drug Administration, 5630 Fishers
disease, intended to support a health Innovation, is announcing a public Lane, Rm. 1061, Rockville, MD 20852.
claim, and conducted in a population workshop entitled ‘‘Clinical Trials— • For written/paper comments
that does not include individuals less Assessing Safety and Efficacy in Diverse submitted to the Division of Dockets
than 12 months old, those with altered Populations.’’ The purpose of the Management, FDA will post your
immune systems, or those with serious meeting is to discuss approaches in comment, as well as any attachments,
or life-threatening medical conditions; clinical trial design and subgroup except for information submitted,
• Clinical studies designed to marked and identified, as confidential,
analyses for therapeutic product
evaluate whether a food substance if submitted as detailed in
development and life-cycle
tkelley on DSK3SPTVN1PROD with NOTICES
reduces the risk of a disease, intended ‘‘Instructions.’’
management.
to support a new or expanded health Instructions: All submissions received
claim, and conducted in a population DATES:The meeting will be held on must include the Docket No. FDA–
that includes individuals less than 12 December 2, 2015, from 9 a.m. to 5 p.m. 2015–N–3805 for Clinical Trials—
months old, those with altered immune ADDRESSES: The meeting will be held at Assessing Safety and Efficacy for
systems, or those with serious or life- the FDA White Oak Campus, 10903 Diverse Populations; Public Meeting;
threatening medical conditions. New Hampshire Ave., Bldg. 31 Request for Comments. Received
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![66910 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices
comments will be placed in the docket of participant diversity in the design, DEPARTMENT OF HEALTH AND
and, except for those submitted as analysis, and regulation of medical HUMAN SERVICES
‘‘Confidential Submissions,’’ publicly interventions. Medical interventions
viewable at http://www.regulations.gov may have different benefits and harms Food and Drug Administration
or at the Division of Dockets for subgroups within a population. If
Management between 9 a.m. and 4 p.m., clinical trials do not include an [Docket No. FDA–2014–D–1167]
Monday through Friday. adequate number of participants who
• Confidential Submissions—To are representative of people likely to use Agency Information Collection
submit a comment with confidential an approved intervention, then the Activities; Announcement of Office of
information that you do not wish to be average results of clinical trials might Management and Budget Approval;
made publicly available, submit your Guidance for Industry on Controlled
not be replicated in practice. Even if
comments only as a written/paper Correspondence Related to Generic
clinical trials include representative
submission. You should submit two Drug Development
participants, important subgroup
copies total. One copy will include the
information you claim to be confidential differences might not be detectable if
their representation is not adequate. For AGENCY: Food and Drug Administration,
with a heading or cover note that states HHS.
‘‘THIS DOCUMENT CONTAINS these reasons, regulators might use a
CONFIDENTIAL INFORMATION’’. The combination of information from ACTION: Notice.
Agency will review this copy, including clinical trials and other data sources to
the claimed confidential information, in address questions about heterogeneity SUMMARY: The Food and Drug
its consideration of comments. The across large and diverse populations. Administration (FDA) is announcing
second copy, which will have the The use of data from patients in their that a collection of information entitled
claimed confidential information usual care setting (‘‘real-world’’ data) ‘‘Guidance for Industry on Controlled
redacted/blacked out, will be available may be particularly valuable for Correspondence Related to Generic Drug
for public viewing and posted on understanding this heterogeneity. Development’’ has been approved by the
http://www.regulations.gov. Submit Agenda: The agenda is located at: Office of Management and Budget
both copies to the Division of Dockets http://www.jhsph.edu/research/centers- (OMB) under the Paperwork Reduction
Management. If you do not wish your and-institutes/center-of-excellence-in- Act of 1995.
name and contact information to be regulatory-science-and-innovation/
made publicly available, you can FOR FURTHER INFORMATION CONTACT: FDA
news-and-events/clinical-trials- PRA Staff, Office of Operations, Food
provide this information on the cover
assessing-safety-and-efficacy-for- and Drug Administration, 8455
sheet and not in the body of your
diverse-population.html. (FDA has Colesville Rd., COLE–14526, Silver
comments and you must identify this
information as ‘‘confidential.’’ Any verified the Web site addresses Spring, MD 20993–0002, PRAStaff@
information marked as ‘‘confidential’’ throughout this notice, but FDA is not fda.hhs.gov.
will not be disclosed except in responsible for subsequent changes to
accordance with 21 CFR 10.20 and other the Web sites after this document SUPPLEMENTARY INFORMATION: On July 9,
applicable disclosure law. For more publishes in the Federal Register). 2015, the Agency submitted a proposed
information about FDA’s posting of Registration: There is no registration collection of information entitled
comments to public dockets, see 80 FR fee to attend this meeting. Seats are ‘‘Guidance for Industry on Controlled
56469, September 18, 2015, or access limited, and registration will be on a Correspondence Related to Generic Drug
the information at: http://www.fda.gov/ first-come, first-served basis. To register, Development’’ to OMB for review and
regulatoryinformation/dockets/ please complete registration online at clearance under 44 U.S.C. 3507. An
default.htm. http://www.surveymonkey.com/r/ Agency may not conduct or sponsor,
Docket: For access to the docket to ClinicalTrialsWorkshop120215. (FDA and a person is not required to respond
read background documents or the has verified the Web address, but FDA to, a collection of information unless it
electronic and written/paper comments is not responsible for subsequent displays a currently valid OMB control
received, go to http:// number. OMB has now approved the
changes to the Web site after this
www.regulations.gov and insert the information collection and has assigned
document publishes in the Federal
docket number, found in brackets in the OMB control number 0910–0797. The
heading of this document, into the Register.)
approval expires on September 30,
‘‘Search’’ box and follow the prompts Accommodations: Attendees are
2018. A copy of the supporting
and/or go to the Division of Dockets responsible for their own hotel
statement for this information collection
Management, 5630 Fishers Lane, Rm. accommodations. If you need special
is available on the Internet at http://
1061, Rockville, MD 20852. accommodations due to a disability,
www.reginfo.gov/public/do/PRAMain.
FOR FURTHER INFORMATION CONTACT: please contact Jill Zung at
Martin Mendoza, Office of Minority Jill.Zung@fda.hhs.gov at least 7 days in Dated: October 26, 2015.
Health, Food and Drug Administration, advance. Leslie Kux,
10903 New Hampshire Ave., Bldg. 32, Dated: October 26, 2015. Associate Commissioner for Policy.
Rm. 2306, Silver Spring, MD 20993– [FR Doc. 2015–27741 Filed 10–29–15; 8:45 am]
Leslie Kux,
0002, Martin.Mendoza@fda.hhs.gov. BILLING CODE 4164–01–P
Associate Commissioner for Policy.
tkelley on DSK3SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: The
[FR Doc. 2015–27728 Filed 10–29–15; 8:45 am]
purpose of this public workshop is to
facilitate a unique opportunity for BILLING CODE 4164–01–P
relevant stakeholders, including
industry, academia, patients, and FDA,
to discuss the importance of diversity in
medical research and the incorporation
VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/80_FR_67119/page/2.svg)
Document Created: 2015-12-14 15:29:35
Document Modified: 2015-12-14 15:29:35
| 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 of meeting; request for comments. | |
| Dates | The meeting will be held on December 2, 2015, from 9 a.m. to 5 p.m. | |
| Contact | Martin Mendoza, Office of Minority Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2306, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 80 FR 66909 |
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