Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases, 81340-81341 [2015-32724]

Download as PDF asabaliauskas on DSK5VPTVN1PROD with NOTICES 81340 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for paliperidone palmitate extended-release injectable suspension. FDA initially approved new drug application 022264 for INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension. There are no approved ANDAs for this product. In August 2011, we issued a draft guidance for industry on BE recommendations for paliperidone palmitate extended-release injectable suspension, which we subsequently revised in December 2013. We are now issuing a further revised draft guidance for industry on BE recommendations for generic paliperidone palmitate extended-release injectable suspension (‘‘Draft Guidance on Paliperidone Palmitate’’). In May 2013, Janssen Research and Development, LLC, manufacturer of the reference listed drug, INVEGA SUSTENNA, submitted a citizen petition requesting that FDA require that any ANDA referencing INVEGA SUSTENNA extended-release injectable suspension meet certain conditions related to demonstrating BE (Docket No. FDA–2013–P–0608). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the Draft Guidance on Paliperidone Palmitate in responding to the petition. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on the design of BE studies to support ANDAs for paliperidone palmitate extended-release injectable suspension. It does not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 Guidances/default.htm or https:// www.regulations.gov. Dated: December 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–32723 Filed 12–28–15; 8:45 am] BILLING CODE 4164–01–P 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. Notice; establishment of docket; request for comments. ACTION: 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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’’). PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 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 https://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 https:// 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: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments E:\FR\FM\29DEN1.SGM 29DEN1 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices received, go to https:// 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 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 lifethreatening 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 https://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. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority 81341 Section RQ–20, Functions Delete the functional statement for the Bureau of Health Workforce (RQ) and replace in its entirety. This notice reflects organizational changes in Bureau of Health Workforce (RQ). Specifically, this notice: (1) Abolish the Office of Workforce Development and Analysis; (RQA); (2) abolishes the Office of Health Careers (RQB); and (3) updates the functional statement for the Bureau of Health Workforce (RQ). Bureau of Health Workforce (RQ) This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) (60 FR 56605, as amended November 6, 1995; as last amended at 80 FR 66545–66546 dated October 29, 2015). This notice reflects organizational changes in the Health Resources and Services Administration (HRSA), Bureau of Health Workforce (RQ). Specifically, this notice: (1) Abolishes the Office of Workforce Development and Analysis (RQA); (2) abolishes the Office of Health Careers (RQB); and (3) updates the functional statement for the Bureau of Health Workforce (RQ). The Bureau of Health Workforce (BHW) improves the health of the nation’s underserved communities and vulnerable populations by developing, implementing, evaluating, and refining programs that strengthen the nation’s health care workforce. BHW programs support a diverse, culturally competent workforce by addressing components including: Education and training; recruitment and retention; financial support for students, faculty, and practitioners; supporting institutions; data analysis; and evaluation and coordination of health workforce activities. These efforts support development of a skilled health workforce serving in areas of the nation with the greatest need. Chapter RQ—Bureau of Health Workforce Office of the Associate Administrator (RQ) Section RQ–10, Organization Delete the organizational structure for the Bureau of Health Workforce (RQ) and replace in its entirety. The Bureau of Health Workforce is headed by the Associate Administrator, who reports directly to the Administrator, Health Resources and Services Administration. 1. Office of the Associate Administrator (RQ); 2. Division of Policy and Shortage Designation (RQ1); 3. Division of Business Operations (RQ2); 4. Division of External Affairs (RQ3); 5. National Center for Health Workforce Analysis (RQ4); 6. Division of Medicine and Dentistry (RQ5); 7. Division of Nursing and Public Health (RQ6); 8. Division of Practitioner Data Bank (RQ7); 9. Division of Participant Support and Compliance (RQ8); 10. Division of Health Careers and Financial Support (RQ9); 11. Division of National Health Service Corps (RQC); and 12. Division of Regional Operations (RQD). The Office of the Associate Administrator provides overall leadership, direction, coordination, and planning in support of the BHW’s programs designed to help meet the health professions workforce needs of the nation and improve the health of the nation’s underserved communities and vulnerable populations. The office guides and directs the bureau’s workforce analysis efforts and provides guidance and support for advisory councils. Additionally, the office provides direction by coordinating the recruitment, education, training, and retention of diverse health professionals in the healthcare system and supporting communities’ efforts to build more integrated and sustainable systems of care. Specifically: (1) Directs and provides policy guidance for workforce recruitment, student and faculty assistance, training, and placement of health professionals to serve in underserved areas; (2) directs the bureau’s health professions workforce data collection and analysis efforts in support of BHW’s programs, and provides oversight for the evaluation of grantee performance and program outcomes; (3) guides and supports work PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

Agencies

[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81340-81341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32724]


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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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 https://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
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