81 FR 69537 - Tropical Disease Priority Review Vouchers; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 194 (October 6, 2016)

Page Range		69537-69538
FR Document		2016-24232

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 This guidance finalizes the draft guidance of the same name issued October 2008.

Federal Register, Volume 81 Issue 194 (Thursday, October 6, 2016)

[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Pages 69537-69538]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-24232]

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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.

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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 This guidance finalizes the draft guidance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: 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-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 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.
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
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://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

69538 Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices

approval for pharmaceutical treatments Dated: September 30, 2016. the preparation of its 23rd report.
for these diseases. Under section 524, a Leslie Kux, COGME’s reports are submitted to the
sponsor of a human drug application for Associate Commissioner for Policy. Secretary of HHS; the Committee on
a qualified tropical disease may be [FR Doc. 2016–24232 Filed 10–5–16; 8:45 am] Health, Education, Labor, and Pensions
eligible for a voucher that can be used BILLING CODE 4164–01–P
of the Senate; and the Committee on
to obtain a priority review for any Energy and Commerce of the House of
application submitted under section Representatives.
505(b)(1) of the FD&C Act or section 351 DEPARTMENT OF HEALTH AND Members of the public will have the
of the Public Health Service Act. The HUMAN SERVICES opportunity to provide comments. Oral
guidance also provides information on comments will be honored in the order
using the priority review vouchers and Health Resources and Services they are requested and may be limited
on transferring priority review vouchers Administration as time allows. Requests to make oral
to other sponsors. comments or provide written comments
This guidance finalizes the draft Council on Graduate Medical to COGME should be made using the
guidance of the same name issued Education contact address or phone number above
October 2008 and includes the AGENCY: Health Resources and Service by October 13, 2016.
following substantive changes based on Administration (HRSA), Department of Jason E. Bennett,
public comment. Health and Human Services (HHS). Director, Division of the Executive Secretariat.
• The procedure for FDA to add ACTION: Notice of meeting. [FR Doc. 2016–24167 Filed 10–5–16; 8:45 am]
diseases to the list is described
• Clarification is provided for when a
BILLING CODE 4165–15–P
SUMMARY: In accordance with the
voucher can be used Federal Advisory Committee Act, notice
• A statement was added to say that is hereby given that a meeting is DEPARTMENT OF HEALTH AND
FDA may provide a preliminary scheduled for the Council on Graduate HUMAN SERVICES
nonbinding opinion, before approval, Medical Education (COGME). This
that an application appears to meet the meeting will be open to the public. Meeting of the Secretary’s Advisory
criteria for voucher eligibility Information about COGME and the Committee on Human Research
• Clarification is provided regarding agenda for this meeting can be obtained Protections
the eligibility of combination products by accessing the COGME Web site at
to receive a voucher http://www.hrsa.gov/ AGENCY: Office of the Secretary, Office
• Clarification is provided regarding advisorycommittees/bhpradvisory/ of the Assistant Secretary for Health,
the timing of payment of the priority COGME. Department of Health and Human
review user fee Services.
DATES: October 20, 2016, 10:00 a.m.–
• Clarification is provided regarding 4:30 p.m. ET
ACTION: Notice.
whether FDA can remove tropical
ADDRESSES: This meeting will be held SUMMARY: Pursuant to Section 10(a) of
diseases from the list
by webinar only. Information on the Federal Advisory Committee Act,
This guidance is being issued connecting to the webinar can be found U.S.C. Appendix 2, notice is hereby
consistent with FDA’s good guidance on the COGME Web site. given that the Secretary’s Advisory
practices regulation (21 CFR 10.115). Committee on Human Research
FOR FURTHER INFORMATION CONTACT:
The guidance represents the current Protections (SACHRP) will hold a
thinking of FDA on obtaining tropical Anyone requesting information
regarding COGME should contact Dr. meeting that will be open to the public.
disease priority review vouchers. It does Information about SACHRP and the full
not establish any rights for any person Kennita Carter, Designated Federal
Official, Division of Medicine and meeting agenda will be posted on the
and is not binding on FDA or the public. SACHRP Web site at: http://
You can use an alternative approach if Dentistry, Bureau of Health Workforce,
HRSA, in one of three ways: (1) Send a www.dhhs.gov/ohrp/sachrp-committee/
it satisfies the requirements of the meetings/index.html.
applicable statutes and regulations. request to the following address: Dr.
Kennita Carter, Designated Federal DATES: The meeting will be held on
II. Paperwork Reduction Act of 1995 Official, Division of Medicine and Tuesday, October 25, 2016, from 8:30
Dentistry, HRSA, 5600 Fishers Lane, a.m. until 5:00 p.m. and Wednesday,
This guidance contains information
15N–116, Rockville, Maryland 20857; October 26, 2016, from 8:30 a.m. until
collection provisions that are subject to
(2) call 301–945–3505; or (3) send an 4:30 p.m.
review by the Office of Management and
Budget (OMB) under the Paperwork email to KCarter@hrsa.gov. ADDRESSES: Fishers Lane Conference
Reduction Act of 1995 (44 U.S.C. 3501– SUPPLEMENTARY INFORMATION: COGME Center, Terrace Level, 5635 Fishers
3520). The collection of information in provides advice and recommendations Lane, Rockville, Maryland 20852.
this guidance was approved under OMB to the Secretary of HHS and to Congress FOR FURTHER INFORMATION CONTACT: Julia
control number 0910–0822. on a range of issues including the Gorey, J.D., Executive Director, SACHRP
supply and distribution of physicians in or Jerry Menikoff, M.D., J.D., Director,
III. Electronic Access the United States, current and future Office for Human Research Protections
Persons with access to the Internet physician shortages or excesses, foreign (OHRP); U.S. Department of Health and
may obtain the guidance at http:// medical school graduates, the nature Human Services, 1101 Wootton
sradovich on DSK3GMQ082PROD with NOTICES

www.fda.gov/Drugs/Guidance and financing of medical education Parkway, Suite 200, Rockville,
ComplianceRegulatoryInformation/ training, and the development of Maryland 20852; telephone: 240–453–
Guidances/default.htm, http:// performance measures and longitudinal 8141; fax: 240–453–6909; email address:
www.fda.gov/BiologicsBloodVaccines/ evaluation of medical education SACHRP@hhs.gov.
GuidanceCompliance programs. SUPPLEMENTARY INFORMATION: Under the
RegulatoryInformation/default.htm, or During the meeting, COGME members authority of 42 U.S.C. 217a, Section 222
http://www.regulations.gov. will discuss topics and issues related to of the Public Health Service Act, as

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Document Created: 2016-10-06 02:37:33
Document Modified: 2016-10-06 02:37:33

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 availability.
Dates		Submit either electronic or written comments on Agency guidances at any time.
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.
FR Citation		81 FR 69537

81 FR 69537 - Tropical Disease Priority Review Vouchers; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 194 (October 6, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration