80 FR 81340 - Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 249 (December 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 249 (December 29, 2015)
| Page Range | 81340-81341 | |
| FR Document | 2015-32724 |
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)] [Notices] [Pages 81340-81341] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32724] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-4170] Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs. DATES: Submit either electronic or written comments on the collection of information by January 28, 2016. ADDRESSES: 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-4170 for ``Clinical Trial Designs in Emerging Infectious Diseases.'' 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 [[Page 81341]] 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. SUPPLEMENTARY INFORMATION: FDA held a workshop on ``Clinical Trial Designs in Emerging Infectious Diseases'' in partnership with the National Institute of Allergy and Infectious Diseases, the HHS Office of the Assistant Secretary for Preparedness and Response, and the Centers for Disease Control and Prevention as a step in collecting information. The objectives of the workshop were to: (1) Discuss the deployment of investigational products in the context of emerging infectious diseases, drawing on the lessons learned in the Ebola virus epidemic; (2) explore the strengths and weaknesses of different clinical trial designs for establishing the safety and efficacy of investigational products for the treatment and/or prevention of life- threatening emerging infectious diseases (EID) in resource-limited settings from scientific, ethical, and operational perspectives; (3) identify areas of consensus and areas needing further discussion, with the goal of formulating acceptable options for the deployment of investigational products in clinical trials for future EIDs; and (4) discuss planning and other factors that can impact on the ability to establish clinical trials in a timely fashion to evaluate investigational therapies. The meeting agenda, transcripts, and web cast recordings are available on the FDA Web site at http://www.fda.gov/emergencypreparedness/counterterrorism/medicalcountermeasures/aboutmcmi/ucm466153.htm. The meeting agenda and transcripts will also be available in the docket. FDA is opening this docket to provide an avenue for the public to submit additional information that may be relevant to the design and conduct of clinical trials for establishing the safety and efficacy of investigational products for the treatment and/or prevention of life- threatening emerging infectious diseases. Individuals submitting comments are specifically invited to address the scientific, ethical, and practical considerations that should be taken into account when designing and implementing clinical trials for future emerging infectious diseases in resource-limited settings. Dated: December 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-32724 Filed 12-28-15; 8:45 am] BILLING CODE 4164-01-P
![81340 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
that would be used to make product- Guidances/default.htm or http:// Written/Paper Submissions
specific BE recommendations available www.regulations.gov. Submit written/paper submissions as
to the public on FDA’s Web site at Dated: December 23, 2015. follows:
http://www.fda.gov/Drugs/Guidance Leslie Kux, • Mail/Hand delivery/Courier (for
ComplianceRegulatoryInformation/ Associate Commissioner for Policy. written/paper submissions): Division of
Guidances/default.htm. Dockets Management (HFA–305), Food
[FR Doc. 2015–32723 Filed 12–28–15; 8:45 am]
As described in that guidance, FDA and Drug Administration, 5630 Fishers
BILLING CODE 4164–01–P
adopted this process to develop and Lane, rm. 1061, Rockville, MD 20852.
disseminate product-specific BE • For written/paper comments
recommendations and to provide a DEPARTMENT OF HEALTH AND submitted to the Division of Dockets
meaningful opportunity for the public to HUMAN SERVICES Management, FDA will post your
consider and comment on those comment, as well as any attachments,
recommendations. This notice Food and Drug Administration except for information submitted,
announces the availability of draft BE marked and identified, as confidential,
[Docket No. FDA–2015–N–4170]
recommendations for paliperidone if submitted as detailed in
palmitate extended-release injectable Establishment of a Public Docket; ‘‘Instructions.’’
suspension. FDA initially approved new Clinical Trial Designs in Emerging Instructions: All submissions received
drug application 022264 for INVEGA Infectious Diseases must include the Docket No. FDA–
SUSTENNA (paliperidone palmitate) 2015–N–4170 for ‘‘Clinical Trial Designs
extended-release injectable suspension. AGENCY: Food and Drug Administration, in Emerging Infectious Diseases.’’
There are no approved ANDAs for this HHS. Received comments will be placed in
product. In August 2011, we issued a ACTION: Notice; establishment of docket; the docket and, except for those
draft guidance for industry on BE request for comments. submitted as ‘‘Confidential
recommendations for paliperidone Submissions,’’ publicly viewable at
palmitate extended-release injectable SUMMARY: The Food and Drug
Administration (FDA) is establishing a http://www.regulations.gov or at the
suspension, which we subsequently Division of Dockets Management
revised in December 2013. We are now public docket to receive input on
clinical trial designs in emerging between 9 a.m. and 4 p.m., Monday
issuing a further revised draft guidance through Friday.
infectious diseases. Interested parties
for industry on BE recommendations for
are invited to submit comments, • Confidential Submissions—To
generic paliperidone palmitate submit a comment with confidential
supported by research and data,
extended-release injectable suspension information that you do not wish to be
regarding clinical trial designs.
(‘‘Draft Guidance on Paliperidone made publicly available, submit your
Palmitate’’). DATES: Submit either electronic or
comments only as a written/paper
In May 2013, Janssen Research and written comments on the collection of
information by January 28, 2016. submission. You should submit two
Development, LLC, manufacturer of the copies total. One copy will include the
reference listed drug, INVEGA ADDRESSES: You may submit comments
information you claim to be confidential
SUSTENNA, submitted a citizen as follows: with a heading or cover note that states
petition requesting that FDA require Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
that any ANDA referencing INVEGA CONFIDENTIAL INFORMATION.’’ The
Submit electronic comments in the
SUSTENNA extended-release injectable Agency will review this copy, including
following way:
suspension meet certain conditions • Federal eRulemaking Portal: http:// the claimed confidential information, in
related to demonstrating BE (Docket No. www.regulations.gov. Follow the its consideration of comments. The
FDA–2013–P–0608). FDA is reviewing instructions for submitting comments. second copy, which will have the
the issues raised in the petition. FDA Comments submitted electronically, claimed confidential information
will consider any comments on the including attachments, to http:// redacted/blacked out, will be available
Draft Guidance on Paliperidone www.regulations.gov will be posted to for public viewing and posted on http://
Palmitate in responding to the petition. the docket unchanged. Because your www.regulations.gov. Submit both
This draft guidance is being issued comment will be made public, you are copies to the Division of Dockets
consistent with FDA’s good guidance solely responsible for ensuring that your Management. If you do not wish your
practices regulation (21 CFR 10.115). comment does not include any name and contact information to be
The draft guidance, when finalized, will confidential information that you or a made publicly available, you can
represent the Agency’s current thinking third party may not wish to be posted, provide this information on the cover
on the design of BE studies to support such as medical information, your or sheet and not in the body of your
ANDAs for paliperidone palmitate anyone else’s Social Security number, or comments and you must identify this
extended-release injectable suspension. confidential business information, such information as ‘‘confidential.’’ Any
It does not create or confer any rights for as a manufacturing process. Please note information marked as ‘‘confidential’’
or on any person and do not operate to that if you include your name, contact will not be disclosed except in
bind FDA or the public. You can use an information, or other information that accordance with 21 CFR 10.20 and other
alternative approach if it satisfies the identifies you in the body of your applicable disclosure law. For more
requirements of the applicable statutes information about FDA’s posting of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
comments, that information will be
and regulations. posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
II. Electronic Access
do not wish to be made available to the regulatoryinformation/dockets/
Persons with access to the Internet public, submit the comment as a default.htm.
may obtain the document at either written/paper submission and in the Docket: For access to the docket to
http://www.fda.gov/Drugs/Guidance manner detailed (see ‘‘Written/Paper read background documents or the
ComplianceRegulatoryInformation/ Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
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![Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices 81341
received, go to http:// Dated: December 23, 2015. Section RQ–20, Functions
www.regulations.gov and insert the Leslie Kux,
Delete the functional statement for the
docket number, found in brackets in the Associate Commissioner for Policy. Bureau of Health Workforce (RQ) and
heading of this document, into the [FR Doc. 2015–32724 Filed 12–28–15; 8:45 am] replace in its entirety.
‘‘Search’’ box and follow the prompts BILLING CODE 4164–01–P This notice reflects organizational
and/or go to the Division of Dockets changes in Bureau of Health Workforce
Management, 5630 Fishers Lane, rm. (RQ). Specifically, this notice: (1)
1061, Rockville, MD 20852. DEPARTMENT OF HEALTH AND Abolish the Office of Workforce
HUMAN SERVICES Development and Analysis; (RQA); (2)
SUPPLEMENTARY INFORMATION: FDA held
a workshop on ‘‘Clinical Trial Designs Health Resources and Services abolishes the Office of Health Careers
in Emerging Infectious Diseases’’ in Administration (RQB); and (3) updates the functional
partnership with the National Institute statement for the Bureau of Health
of Allergy and Infectious Diseases, the Statement of Organization, Functions Workforce (RQ).
HHS Office of the Assistant Secretary and Delegations of Authority Bureau of Health Workforce (RQ)
for Preparedness and Response, and the This notice amends Part R of the The Bureau of Health Workforce
Centers for Disease Control and Statement of Organization, Functions (BHW) improves the health of the
Prevention as a step in collecting and Delegations of Authority of the nation’s underserved communities and
information. The objectives of the Department of Health and Human vulnerable populations by developing,
workshop were to: (1) Discuss the Services (HHS), Health Resources and implementing, evaluating, and refining
deployment of investigational products Services Administration (HRSA) (60 FR programs that strengthen the nation’s
in the context of emerging infectious 56605, as amended November 6, 1995; health care workforce. BHW programs
diseases, drawing on the lessons learned as last amended at 80 FR 66545–66546 support a diverse, culturally competent
in the Ebola virus epidemic; (2) explore dated October 29, 2015). workforce by addressing components
the strengths and weaknesses of This notice reflects organizational including: Education and training;
different clinical trial designs for changes in the Health Resources and recruitment and retention; financial
establishing the safety and efficacy of Services Administration (HRSA), support for students, faculty, and
investigational products for the Bureau of Health Workforce (RQ). practitioners; supporting institutions;
treatment and/or prevention of life- Specifically, this notice: (1) Abolishes data analysis; and evaluation and
threatening emerging infectious diseases the Office of Workforce Development coordination of health workforce
(EID) in resource-limited settings from and Analysis (RQA); (2) abolishes the activities. These efforts support
scientific, ethical, and operational Office of Health Careers (RQB); and (3) development of a skilled health
perspectives; (3) identify areas of updates the functional statement for the workforce serving in areas of the nation
consensus and areas needing further Bureau of Health Workforce (RQ). with the greatest need.
discussion, with the goal of formulating Chapter RQ—Bureau of Health Office of the Associate Administrator
acceptable options for the deployment Workforce (RQ)
of investigational products in clinical
trials for future EIDs; and (4) discuss Section RQ–10, Organization The Office of the Associate
planning and other factors that can Delete the organizational structure for Administrator provides overall
impact on the ability to establish the Bureau of Health Workforce (RQ) leadership, direction, coordination, and
clinical trials in a timely fashion to and replace in its entirety. planning in support of the BHW’s
evaluate investigational therapies. The The Bureau of Health Workforce is programs designed to help meet the
meeting agenda, transcripts, and web headed by the Associate Administrator, health professions workforce needs of
cast recordings are available on the FDA who reports directly to the the nation and improve the health of the
Web site at http://www.fda.gov/ Administrator, Health Resources and nation’s underserved communities and
emergencypreparedness/ Services Administration. vulnerable populations. The office
counterterrorism/ 1. Office of the Associate guides and directs the bureau’s
medicalcountermeasures/aboutmcmi/ Administrator (RQ); workforce analysis efforts and provides
2. Division of Policy and Shortage guidance and support for advisory
ucm466153.htm. The meeting agenda
Designation (RQ1); councils. Additionally, the office
and transcripts will also be available in 3. Division of Business Operations
the docket. provides direction by coordinating the
(RQ2); recruitment, education, training, and
FDA is opening this docket to provide 4. Division of External Affairs (RQ3); retention of diverse health professionals
an avenue for the public to submit 5. National Center for Health in the healthcare system and supporting
additional information that may be Workforce Analysis (RQ4); communities’ efforts to build more
relevant to the design and conduct of 6. Division of Medicine and Dentistry
integrated and sustainable systems of
clinical trials for establishing the safety (RQ5);
7. Division of Nursing and Public care. Specifically: (1) Directs and
and efficacy of investigational products provides policy guidance for workforce
for the treatment and/or prevention of Health (RQ6);
8. Division of Practitioner Data Bank recruitment, student and faculty
life-threatening emerging infectious assistance, training, and placement of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
(RQ7);
diseases. Individuals submitting 9. Division of Participant Support and health professionals to serve in
comments are specifically invited to Compliance (RQ8); underserved areas; (2) directs the
address the scientific, ethical, and 10. Division of Health Careers and bureau’s health professions workforce
practical considerations that should be Financial Support (RQ9); data collection and analysis efforts in
taken into account when designing and 11. Division of National Health support of BHW’s programs, and
implementing clinical trials for future Service Corps (RQC); and provides oversight for the evaluation of
emerging infectious diseases in 12. Division of Regional Operations grantee performance and program
resource-limited settings. (RQD). outcomes; (3) guides and supports work
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Document Created: 2015-12-29 10:14:56
Document Modified: 2015-12-29 10:14:56
| 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; establishment of docket; request for comments. | |
| Dates | Submit either electronic or written comments on the collection of information by January 28, 2016. | |
| FR Citation | 80 FR 81340 |
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