Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability, 31794-31795 [2010-13420]
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31794
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
abundant secreted proteins from the
salivary glands of the sand fly
Lutzomyia longipalpis, vector of
Leishmania chagasi. J Exp Biol. 2004
Oct; 207(Pt 21):3717–3729. [PubMed:
15371479]
3. Valenzuela JG, Belkaid Y, Garfield
MK, Mendez S, Kamhawi S, Rowton ED,
Sacks DL, Ribeiro JM. Toward a defined
anti-Leishmania vaccine targeting vector
antigens: Characterization of a
protective salivary protein. J Exp Med.
2001 Aug 6; 194(3):331–342. [PubMed:
11489952]
4. Belkaid Y., Valenzuela JG,
Kamhawi S., Rowton E., Sacks DL,
Ribeiro JM. Delayed-type
hypersensitivity to Phlebotomus
papatasi sand fly bite: An adaptive
response induced by the fly? Proc Natl
Acad Sci U S A. 2000 Jun 6;
97(12):6704–6709. [PubMed: 10841567]
srobinson on DSKHWCL6B1PROD with NOTICES
• U.S. Patent Application No. 60/
422,303 filed October 29, 2002 (HHS
Ref. No. E–285–2002/0–US–01).
• PCT Application No. PCT/US2003/
03453 filed October 29, 2003 (HHS Ref.
No E–285–2002/0–PCT–02).
Application filed in the following
countries: the USA, Europe, Brazil,
Japan, Mexico, India and Israel.
• U.S. Patent No. 7,485,386 issued
February 3, 2009 (HHS Reference No. E–
285–2002/0–US–03).
• European Patent Number No.
1572968 issued April 22, 2009 (HHS
Reference No. E–285–2002/0–EP–04).
• PCT Application No. PCT/US2009/
042980 filed May 05, 2009 (HHS
Reference No. E–189–2008/2–PCT–01).
• U.S. Patent Application No. 60/
421,327 filed September 19, 2002 (HHS
Ref. No. E–130–2002/0–US–01).
• PCT Application No. PCT/US03/
29833 filed September 18, 2003 (HHS
Ref. No. E–130–2002/0–PCT–02).
Application filed in the following
countries: USA, Europe, Brazil, Japan,
Mexico, India and Israel.
Licensing Status: Available for
licensing.
Licensing Contact: John Stansberry,
PhD; 301–435–5236;
stansbej@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID, OTD is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize ‘‘Vaccines Comprising
Sand Fly Salivary Proteins for Control of
Leishmania Infection’’. Please contact
Dana Hsu at 301–451–3521 for more
information.
16:01 Jun 03, 2010
[FR Doc. 2010–13480 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0406]
Information Sheet Guidance for
Sponsors, Clinical Investigators, and
IRBs; Frequently Asked Questions—
Statement of Investigator (Form FDA
1572); Availability
AGENCY:
Jkt 220001
Food and Drug Administration,
HHS.
ACTION:
Patent Status
VerDate Mar<15>2010
Dated: May 26, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of an information sheet
guidance entitled, ‘‘Information Sheet
Guidance for Sponsors, Clinical
Investigators, and IRBs; Frequently
Asked Questions—Statement of
Investigator (Form FDA 1572).’’ This
guidance is intended to assist sponsors,
clinical investigators, and institutional
review boards (IRBs) involved in
clinical investigations of investigational
drugs and biologics in completing the
Statement of Investigator form (Form
FDA 1572). FDA developed this
information sheet guidance in response
to numerous questions from the
research community regarding Form
FDA 1572. This information sheet
guidance provides FDA’s responses to
the most frequently asked questions.
DATES: Submit either written or
electronic comments on agency
guidances at any time.
ADDRESSES: Submit written requests for
single copies of the guidance to the
Division of Drug Information (HFD–
240), 10903 New Hampshire Ave.,
Silver Spring, MD 20993 or to the Office
of Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the information
sheet guidance document.
FOR FURTHER INFORMATION CONTACT:
Joseph Salewski, Division of Scientific
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Investigations, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring MD 20993, 301–
796–3395.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
an information sheet guidance entitled,
‘‘Information Sheet Guidance for
Sponsors, Clinical Investigators, and
IRBs; Frequently Asked Questions—
Statement of Investigator (Form FDA
1572).’’ This guidance is intended to
assist sponsors, clinical investigators,
and IRBs involved in clinical
investigations of investigational drugs
and biologics in complying with the
requirement that each investigator
complete and sign a Form FDA 1572
before participating in an investigation.
This guidance describes how to
complete the Statement of Investigator
form (Form FDA 1572).
FDA developed this information sheet
guidance in response to numerous
questions from the research community
regarding the Form FDA 1572. In this
guidance, we provide answers to
frequently asked questions concerning
the purpose of this form, when this form
needs to be completed and signed by the
investigator, how to best complete the
various blocks within the form, and
when the form might need to be
updated. In addition, we clarify
questions related to the use of Form
FDA 1572 by clinical investigators
participating in studies conducted
outside the United States that may or
may not be under an investigational
new drug application.
This information sheet guidance is
part of the Information Sheet Guidance
Initiative, announced on February 3,
2006, in the Federal Register (71 FR
5861), which describes FDA’s intention
to update the process for developing,
issuing, and making available guidances
intended for IRBs, clinical investigators,
and sponsors. Known as ‘‘Information
Sheets,’’ these guidances have provided
recommendations to IRBs, clinical
investigators, and sponsors to help them
fulfill their responsibilities to protect
human subjects who participate in
research regulated by the FDA since the
early 1980s. The Information Sheet
Guidance Initiative is intended to
ensure that the Information Sheets are
consistent with the FDA’s good
guidance practices (GGPs). As part of
the initiative, which will be ongoing,
the agency plans to rescind Information
Sheets that are obsolete, revise and
reissue Information Sheet Guidances
that address current issues, and develop
E:\FR\FM\04JNN1.SGM
04JNN1
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
new Information Sheet Guidances as
needed.
In the Federal Register of July 29,
2008 (73 FR 43940), FDA announced the
availability of a draft version of the
guidance entitled, ‘‘Draft Information
Sheet Guidance for Sponsors, Clinical
Investigators, and IRBs; Frequently
Asked Questions—Statement of
Investigator (Form FDA 1572).’’ The July
2008 guidance gave interested persons
an opportunity to submit comments
through September 29, 2008. All
comments received during the comment
period have been carefully reviewed
and, where appropriate, incorporated in
the guidance. As a result of the public
comments and editorial changes, the
guidance is clearer than the draft
version.
This information sheet guidance is
being issued consistent with FDA’s
GGPs regulation (21 CFR 10.115). The
information sheet guidance represents
the agency’s current thinking on
completing the Form FDA 1572. 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. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information 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 collections of information for
Form FDA 1572 have been approved
under OMB Control No. 0910–0014.
III. Comments
srobinson on DSKHWCL6B1PROD with NOTICES
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance7
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13420 Filed 6–3–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review, Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cell Death
in Neurodegeneration.
Date: June 11, 2010.
Time: 9 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites, 1250 22nd Street,
NW., Washington, DC 20037.
Contact Person: Seetha Bhagavan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 27, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13412 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
31795
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, Pediatric Trials
Network.
Date: June 23, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Sathasiva B. Kandasamy,
PhD, Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, 6100 Executive Boulevard,
Room 5B01, Bethesda, MD 20892–9304. (301)
435–6680. skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: May 26, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13482 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities;
Recombinant DNA Research:
Amended Notice of Meeting
ACTION: Notice of cancellation of
consideration of a proposed action
PO 00000
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E:\FR\FM\04JNN1.SGM
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Agencies
[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Pages 31794-31795]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13420]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0406]
Information Sheet Guidance for Sponsors, Clinical Investigators,
and IRBs; Frequently Asked Questions--Statement of Investigator (Form
FDA 1572); Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of an information sheet guidance entitled, ``Information
Sheet Guidance for Sponsors, Clinical Investigators, and IRBs;
Frequently Asked Questions--Statement of Investigator (Form FDA
1572).'' This guidance is intended to assist sponsors, clinical
investigators, and institutional review boards (IRBs) involved in
clinical investigations of investigational drugs and biologics in
completing the Statement of Investigator form (Form FDA 1572). FDA
developed this information sheet guidance in response to numerous
questions from the research community regarding Form FDA 1572. This
information sheet guidance provides FDA's responses to the most
frequently asked questions.
DATES: Submit either written or electronic comments on agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), 10903 New Hampshire Ave.,
Silver Spring, MD 20993 or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist the office in processing your requests. Submit electronic
comments to https://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the information sheet
guidance document.
FOR FURTHER INFORMATION CONTACT: Joseph Salewski, Division of
Scientific Investigations, Office of Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring MD 20993, 301-796-3395.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of an information sheet guidance
entitled, ``Information Sheet Guidance for Sponsors, Clinical
Investigators, and IRBs; Frequently Asked Questions--Statement of
Investigator (Form FDA 1572).'' This guidance is intended to assist
sponsors, clinical investigators, and IRBs involved in clinical
investigations of investigational drugs and biologics in complying with
the requirement that each investigator complete and sign a Form FDA
1572 before participating in an investigation. This guidance describes
how to complete the Statement of Investigator form (Form FDA 1572).
FDA developed this information sheet guidance in response to
numerous questions from the research community regarding the Form FDA
1572. In this guidance, we provide answers to frequently asked
questions concerning the purpose of this form, when this form needs to
be completed and signed by the investigator, how to best complete the
various blocks within the form, and when the form might need to be
updated. In addition, we clarify questions related to the use of Form
FDA 1572 by clinical investigators participating in studies conducted
outside the United States that may or may not be under an
investigational new drug application.
This information sheet guidance is part of the Information Sheet
Guidance Initiative, announced on February 3, 2006, in the Federal
Register (71 FR 5861), which describes FDA's intention to update the
process for developing, issuing, and making available guidances
intended for IRBs, clinical investigators, and sponsors. Known as
``Information Sheets,'' these guidances have provided recommendations
to IRBs, clinical investigators, and sponsors to help them fulfill
their responsibilities to protect human subjects who participate in
research regulated by the FDA since the early 1980s. The Information
Sheet Guidance Initiative is intended to ensure that the Information
Sheets are consistent with the FDA's good guidance practices (GGPs). As
part of the initiative, which will be ongoing, the agency plans to
rescind Information Sheets that are obsolete, revise and reissue
Information Sheet Guidances that address current issues, and develop
[[Page 31795]]
new Information Sheet Guidances as needed.
In the Federal Register of July 29, 2008 (73 FR 43940), FDA
announced the availability of a draft version of the guidance entitled,
``Draft Information Sheet Guidance for Sponsors, Clinical
Investigators, and IRBs; Frequently Asked Questions--Statement of
Investigator (Form FDA 1572).'' The July 2008 guidance gave interested
persons an opportunity to submit comments through September 29, 2008.
All comments received during the comment period have been carefully
reviewed and, where appropriate, incorporated in the guidance. As a
result of the public comments and editorial changes, the guidance is
clearer than the draft version.
This information sheet guidance is being issued consistent with
FDA's GGPs regulation (21 CFR 10.115). The information sheet guidance
represents the agency's current thinking on completing the Form FDA
1572. 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. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information for Form FDA 1572 have been approved under
OMB Control No. 0910-0014.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/Guidance7ComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13420 Filed 6-3-10; 8:45 am]
BILLING CODE 4160-01-S