Draft Guidance for Industry on Tropical Disease Priority Review Vouchers; Availability, 62298-62299 [E8-24932]
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Federal Register / Vol. 73, No. 203 / Monday, October 20, 2008 / Notices
Dated: October 8, 2008.
Sally D. Atwater,
Executive Director, President’s Committee for
People with Intellectual Disabilities.
[FR Doc. E8–24798 Filed 10–17–08; 8:45 am]
Food and Drug Administration
obtained by mail by calling CBER at 1–
800–835–4709 or 301–827–1800.
Submit written comments on the draft
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
[Docket No. FDA–2008–D–0530]
FOR FURTHER INFORMATION CONTACT:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Draft Guidance for Industry on Tropical
Disease Priority Review Vouchers;
Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Tropical Disease
Priority Review Vouchers.’’ There has
been significant outside interest in
FDA’s interpretation of section 1102 of
the Food and Drug Administration
Amendments Act (FDAAA), which adds
a new section 524 to the Federal Food,
Drug, and Cosmetic Act (the act).
Section 524 makes provisions for
awarding priority review vouchers for
future applications to sponsors of
tropical disease product applications
that meet the criteria specified by the
act. This draft guidance explains to
internal and external stakeholders how
FDA intends to implement the
provisions of section 524.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by December 19, 2008.
Submit written comments on the
proposed collection of information by
December 19, 2008.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002, or the
Office of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive label
to assist that office in processing your
requests. The draft guidance may also be
VerDate Aug<31>2005
16:42 Oct 17, 2008
Jkt 217001
David Roeder, Office of Antimicrobial
Products, Center for Drug
Evaluation and Research, Food and
Drug Administration (WO–22), rm.
6410, 0903 New Hampshire Ave.,
Silver Spring, MD 20993–0002,
301–796–0799,or
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448, 301–
827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Tropical Disease Priority Review
Vouchers.’’ Section 1102 of FDAAA
adds new section 524 to the 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 intends to stimulate new drug
development for drugs to treat certain
tropical diseases for which there are no
or few available treatments by offering
additional incentives for obtaining FDA
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 act or section 351 of the
Public Health Service (PHS) Act. The
draft guidance also provides
information on using the priority review
vouchers and on transferring priority
review vouchers to other sponsors.
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 obtaining tropical disease priority
review vouchers. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (the PRA) (44 U.S.C. 3501–
3520), Federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information that they conduct or
sponsor. ‘‘Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA, 44
U.S.C. 3506(c)(2)(A), requires Federal
agencies to provide a 60-day notice in
the Federal Register for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, FDA invites comments on the
following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Under the draft guidance, sponsors of
certain tropical disease drug product
applications submitted under section
505(b)(1) of the act and section 351 of
the PHS Act may request a priority
review voucher. Based on the inquiries
FDA has received on section 524 and
related discussions with sponsors, we
estimate that we will receive annually
approximately five requests from five
sponsors, and that each request will take
approximately 8 hours to prepare and
submit to FDA.
The draft guidance also states that
sponsors should notify FDA of their
intent to use a priority review voucher,
including the date on which the sponsor
intends to submit the application, at
least 1 year before use. We estimate that
we will receive annually approximately
five notifications of intent to use a
voucher from five sponsors, and that
E:\FR\FM\20OCN1.SGM
20OCN1
62299
Federal Register / Vol. 73, No. 203 / Monday, October 20, 2008 / Notices
each notification will take
approximately 8 hours to prepare and
submit to FDA.
The draft guidance also permits the
transfer of a priority review voucher
from one sponsor to another, and states
that each transfer should be
documented with a letter of transfer. We
estimate that we will receive
approximately two letters indicating the
transfer of a voucher from two
application holders, and two letters
from two new voucher owners
acknowledging the transfer, and that it
will take approximately 8 hours to
prepare and submit each letter to FDA.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Reporting Under Section 1102 of
FDAAA
No. of
Respondents
No. responses
per Respondent
Total
Responses
Hours Per
Response
Total Hours
Priority review voucher request
5
1
5
8
40
Notifications of intent to use a
voucher
5
1
5
8
40
Letters indicating the transfer of a
voucher
2
1
2
8
16
Letters acknowledging the receipt
of a transferred voucher.
2
1
2
8
16
Total
1 There
112
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–24932 Filed 10–17–08; 8:45 am]
BILLING CODE 4160–01–S
mstockstill on PROD1PC66 with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
VerDate Aug<31>2005
16:42 Oct 17, 2008
Jkt 217001
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the
Board of Scientific Counselors for Basic
Sciences National Cancer Institute. The
meeting will be closed to the public as
indicated below in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Cancer Institute, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors for Basic Sciences National
Cancer Institute.
Date: November 18, 2008.
Time: 9 a.m. to 2:30 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
National Cancer Institute, 9000 Rockville
Pike, Building 31, Conference Room 6,
Bethesda, MD 20892.
Contact Person: Florence E. Farber, PhD,
Executive Secretary, Office of the Director,
National Cancer Institute, National Institutes
of Health, 6116 Executive Boulevard, Room
2205, Bethesda, MD 20892, 301–496–7628,
ff6p@nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
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Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/bsc/bs/bs.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: October 10, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–24830 Filed 10–17–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the meeting of the
President’s Cancer Panel.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
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20OCN1
]]>Agencies
[Federal Register Volume 73, Number 203 (Monday, October 20, 2008)]
[Notices]
[Pages 62298-62299]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24932]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0530]
Draft Guidance for Industry on Tropical Disease Priority Review
Vouchers; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Tropical
Disease Priority Review Vouchers.'' There has been significant outside
interest in FDA's interpretation of section 1102 of the Food and Drug
Administration Amendments Act (FDAAA), which adds a new section 524 to
the Federal Food, Drug, and Cosmetic Act (the act). Section 524 makes
provisions for awarding priority review vouchers for future
applications to sponsors of tropical disease product applications that
meet the criteria specified by the act. This draft guidance explains to
internal and external stakeholders how FDA intends to implement the
provisions of section 524.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by December 19, 2008. Submit written comments on the proposed
collection of information by December 19, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448. Send one self-addressed adhesive label to assist that
office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
David Roeder, Office of Antimicrobial Products, Center for Drug
Evaluation and Research, Food and Drug Administration (WO-22), rm.
6410, 0903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
0799,or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Tropical Disease Priority Review Vouchers.'' Section 1102 of
FDAAA adds new section 524 to the 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 intends to
stimulate new drug development for drugs to treat certain tropical
diseases for which there are no or few available treatments by offering
additional incentives for obtaining FDA 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 act or section 351
of the Public Health Service (PHS) Act. The draft guidance also
provides information on using the priority review vouchers and on
transferring priority review vouchers to other sponsors.
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 obtaining
tropical disease priority review vouchers. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Under the draft guidance, sponsors of certain tropical disease drug
product applications submitted under section 505(b)(1) of the act and
section 351 of the PHS Act may request a priority review voucher. Based
on the inquiries FDA has received on section 524 and related
discussions with sponsors, we estimate that we will receive annually
approximately five requests from five sponsors, and that each request
will take approximately 8 hours to prepare and submit to FDA.
The draft guidance also states that sponsors should notify FDA of
their intent to use a priority review voucher, including the date on
which the sponsor intends to submit the application, at least 1 year
before use. We estimate that we will receive annually approximately
five notifications of intent to use a voucher from five sponsors, and
that
[[Page 62299]]
each notification will take approximately 8 hours to prepare and submit
to FDA.
The draft guidance also permits the transfer of a priority review
voucher from one sponsor to another, and states that each transfer
should be documented with a letter of transfer. We estimate that we
will receive approximately two letters indicating the transfer of a
voucher from two application holders, and two letters from two new
voucher owners acknowledging the transfer, and that it will take
approximately 8 hours to prepare and submit each letter to FDA.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. responses per Hours Per
Reporting Under Section 1102 of FDAAA Respondents Respondent Total Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Priority review voucher request 5 1 5 8 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notifications of intent to use a voucher 5 1 5 8 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letters indicating the transfer of a voucher 2 1 2 8 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letters acknowledging the receipt of a transferred 2 1 2 8 16
voucher.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 112
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-24932 Filed 10-17-08; 8:45 am]
BILLING CODE 4160-01-S
