Tropical Disease Priority Review Vouchers; Guidance for Industry; Availability, 69537-69538 [2016-24232]

Download as PDF Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices Dated: September 30, 2016. Leslie Kux, Associate Commissioner for Policy. 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’’). [FR Doc. 2016–24233 Filed 10–5–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0530] Tropical Disease Priority Review Vouchers; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Tropical Disease Priority Review Vouchers.’’ There has been significant outside interest in FDA’s interpretation of the priority review voucher section in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Food and Drug Administration Amendments Act (FDAAA). This section makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the FD&C Act. This guidance explains to internal and external stakeholders how FDA is implementing the provisions of this section. This guidance finalizes the draft guidance of the same name issued October 2008. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: sradovich on DSK3GMQ082PROD with NOTICES 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 VerDate Sep<11>2014 18:46 Oct 05, 2016 Jkt 241001 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– 2008–D–0530 for Tropical Disease Priority Review Vouchers; Guidance for Industry; Availability. 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’’ PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 69537 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 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. Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993–0002, 301– 796–1182; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Tropical Disease Priority Review Vouchers.’’ Section 1102 of FDAAA added section 524 to the FD&C Act. Section 524 is designed to encourage development of new drug or biological products for prevention and treatment of certain tropical diseases affecting millions of people throughout the world. By enacting section 524, Congress intended to stimulate new drug development for drug products to treat certain tropical diseases by offering additional incentives for obtaining FDA E:\FR\FM\06OCN1.SGM 06OCN1 69538 Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices approval for pharmaceutical treatments for these diseases. Under section 524, a sponsor of a human drug application for a qualified tropical disease may be eligible for a voucher that can be used to obtain a priority review for any application submitted under section 505(b)(1) of the FD&C Act or section 351 of the Public Health Service Act. The guidance also provides information on using the priority review vouchers and on transferring priority review vouchers to other sponsors. This guidance finalizes the draft guidance of the same name issued October 2008 and includes the following substantive changes based on public comment. • The procedure for FDA to add diseases to the list is described • Clarification is provided for when a voucher can be used • A statement was added to say that FDA may provide a preliminary nonbinding opinion, before approval, that an application appears to meet the criteria for voucher eligibility • Clarification is provided regarding the eligibility of combination products to receive a voucher • Clarification is provided regarding the timing of payment of the priority review user fee • Clarification is provided regarding whether FDA can remove tropical diseases from the list This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on obtaining tropical disease priority review vouchers. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information in this guidance was approved under OMB control number 0910–0822. sradovich on DSK3GMQ082PROD with NOTICES III. Electronic Access Persons with access to the Internet may obtain the guidance at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm, or https://www.regulations.gov. VerDate Sep<11>2014 18:46 Oct 05, 2016 Jkt 241001 Dated: September 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–24232 Filed 10–5–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Council on Graduate Medical Education Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Council on Graduate Medical Education (COGME). This meeting will be open to the public. Information about COGME and the agenda for this meeting can be obtained by accessing the COGME Web site at https://www.hrsa.gov/ advisorycommittees/bhpradvisory/ COGME. SUMMARY: October 20, 2016, 10:00 a.m.– 4:30 p.m. ET ADDRESSES: This meeting will be held by webinar only. Information on connecting to the webinar can be found on the COGME Web site. FOR FURTHER INFORMATION CONTACT: Anyone requesting information regarding COGME should contact Dr. Kennita Carter, Designated Federal Official, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, in one of three ways: (1) Send a request to the following address: Dr. Kennita Carter, Designated Federal Official, Division of Medicine and Dentistry, HRSA, 5600 Fishers Lane, 15N–116, Rockville, Maryland 20857; (2) call 301–945–3505; or (3) send an email to KCarter@hrsa.gov. SUPPLEMENTARY INFORMATION: COGME provides advice and recommendations to the Secretary of HHS and to Congress on a range of issues including the supply and distribution of physicians in the United States, current and future physician shortages or excesses, foreign medical school graduates, the nature and financing of medical education training, and the development of performance measures and longitudinal evaluation of medical education programs. During the meeting, COGME members will discuss topics and issues related to DATES: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 the preparation of its 23rd report. COGME’s reports are submitted to the Secretary of HHS; the Committee on Health, Education, Labor, and Pensions of the Senate; and the Committee on Energy and Commerce of the House of Representatives. Members of the public will have the opportunity to provide comments. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to COGME should be made using the contact address or phone number above by October 13, 2016. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–24167 Filed 10–5–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Office of the Secretary, Office of the Assistant Secretary for Health, Department of Health and Human Services. ACTION: Notice. AGENCY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https:// www.dhhs.gov/ohrp/sachrp-committee/ meetings/. DATES: The meeting will be held on Tuesday, October 25, 2016, from 8:30 a.m. until 5:00 p.m. and Wednesday, October 26, 2016, from 8:30 a.m. until 4:30 p.m. ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers Lane, Rockville, Maryland 20852. FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director, SACHRP or Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP); U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240–453– 8141; fax: 240–453–6909; email address: SACHRP@hhs.gov. SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as SUMMARY: E:\FR\FM\06OCN1.SGM 06OCN1

Agencies

[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Pages 69537-69538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24232]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0530]


Tropical Disease Priority Review Vouchers; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Tropical Disease 
Priority Review Vouchers.'' There has been significant outside interest 
in FDA's interpretation of the priority review voucher section in the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Food 
and Drug Administration Amendments Act (FDAAA). This section makes 
provisions for awarding priority review vouchers for future 
applications to sponsors of tropical disease product applications that 
meet the criteria specified by the FD&C Act. This guidance explains to 
internal and external stakeholders how FDA is implementing the 
provisions of this section. This guidance finalizes the draft guidance 
of the same name issued October 2008.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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-2008-D-0530 for Tropical Disease Priority Review Vouchers; Guidance 
for Industry; Availability. 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 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.
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6360, Silver Spring, MD 20993-0002, 301-
796-1182; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Tropical Disease Priority Review Vouchers.'' Section 1102 of 
FDAAA added section 524 to the FD&C Act. Section 524 is designed to 
encourage development of new drug or biological products for prevention 
and treatment of certain tropical diseases affecting millions of people 
throughout the world. By enacting section 524, Congress intended to 
stimulate new drug development for drug products to treat certain 
tropical diseases by offering additional incentives for obtaining FDA

[[Page 69538]]

approval for pharmaceutical treatments for these diseases. Under 
section 524, a sponsor of a human drug application for a qualified 
tropical disease may be eligible for a voucher that can be used to 
obtain a priority review for any application submitted under section 
505(b)(1) of the FD&C Act or section 351 of the Public Health Service 
Act. The guidance also provides information on using the priority 
review vouchers and on transferring priority review vouchers to other 
sponsors.
    This guidance finalizes the draft guidance of the same name issued 
October 2008 and includes the following substantive changes based on 
public comment.

     The procedure for FDA to add diseases to the list is 
described
     Clarification is provided for when a voucher can be used
     A statement was added to say that FDA may provide a 
preliminary nonbinding opinion, before approval, that an application 
appears to meet the criteria for voucher eligibility
     Clarification is provided regarding the eligibility of 
combination products to receive a voucher
     Clarification is provided regarding the timing of payment 
of the priority review user fee
     Clarification is provided regarding whether FDA can remove 
tropical diseases from the list

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on obtaining tropical disease priority review 
vouchers. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0822.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: September 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24232 Filed 10-5-16; 8:45 am]
BILLING CODE 4164-01-P
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