Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards on Frequently Asked Questions-Statement of Investigator (Form FDA 1572); Availability, 43940-43941 [E8-17305]
Download as PDF
<![CDATA[
43940
Federal Register / Vol. 73, No. 146 / Tuesday, July 29, 2008 / Notices
H. Independent biological or therapeutic the Federal Dockets Management
System (FDMS). FDMS is a
effects on humans
Government-wide, electronic docket
As noted, section 301(ll)(3) provides
management system. Electronic
an exception to the prohibition of
comments or submissions will be
adding a drug or biological product to
accepted by FDA only through FDMS at
a food if use of the drug or biological
https://www.regulations.gov.
product is ‘‘to enhance the safety of the
food * * * and not to have independent
biological or therapeutic effects on
humans.’’
1. What factors should FDA consider
in determining whether the use of a
substance in food is to have a
‘‘biological’’ effect on humans?
2. What factors should FDA consider
in determining whether the use of a
substance in food is to have a biological
effect on humans that is ‘‘independent?’’
3. What factors should FDA consider
in determining whether the use of a
substance in food is to have a
‘‘therapeutic’’ effect on humans?
4. What factors should FDA consider
in determining whether the use of a
substance in food is to have a
therapeutic impact on humans that is
‘‘independent?’’
I. In the Secretary’s Discretion
Section 301(ll)(2) permits the addition
of a drug or biological product to a food
‘‘if the Secretary, in the Secretary’s
discretion, has issued a regulation after
notice and comment, approving the use
* * * in food.’’ As noted, the Secretary
has delegated his authority under the
act to the Commissioner of Food and
Drugs.
1. What factors should the
Commissioner consider in exercising his
discretion under section 301(ll)(2)?
2. What should be the impact, if any,
on the exercise of the Commissioner’s
discretion where use of the drug or
biological product in food has been the
subject of another statutory or
administrative process (e.g., a food
contact substance notification that is
effective under section 409(h))?
jlentini on PROD1PC65 with NOTICES
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
VerDate Aug<31>2005
16:12 Jul 28, 2008
Jkt 214001
Dated: July 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17356 Filed 7–28–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0406]
Draft Information Sheet Guidance for
Sponsors, Clinical Investigators, and
Institutional Review Boards on
Frequently Asked Questions—
Statement of Investigator (Form FDA
1572); Availability
BILLING CODE 4160–01–S
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: July 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17303 Filed 7–28–08; 8:45 am]
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft 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
institutional review boards (IRBs),
clinical investigators, and sponsors
involved in clinical investigations of
investigational drugs and biologics in
completing the Statement of Investigator
form (Form FDA 1572). FDA developed
this draft information sheet guidance in
response to numerous questions from
the research community regarding Form
FDA 1572. This draft information sheet
guidance provides FDA’s responses to
the most frequently asked questions.
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 comments on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft information sheet guidance by
September 29, 2008.
ADDRESSES: Submit written comments
on this draft information sheet 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
information sheet guidance document.
FOR FURTHER INFORMATION CONTACT:
Patricia M. Beers Block, Office of
Science and Health Coordination/Good
Clinical Practice Program (HF–34), Food
and Drug Administration, 5600 Fishers
Lane, Rockville MD 20857, 301–827–
3340.
BILLING CODE 4160–01–S
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
[Docket No. FDA–2007–P–0300] (formerly
2007P–0326)
Determination That SANOREX
(Mazindol) Tablets 1 and 2 Milligrams
Were Not Withdrawn From Sale for
Reasons of Safety or Effectiveness;
Correction
AGENCY:
Food and Drug Administration.
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
July 15, 2008 (73 FR 40582). The
document announced the determination
that SANOREX (mazindol) Tablets, 1
and 2 milligrams (mg), were not
withdrawn from sale for reasons of
safety or effectiveness. The document
was published with an incorrect docket
number. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy and
Planning (HF–27), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7010.
SUPPLEMENTARY INFORMATION: In FR Doc.
E8–15998, appearing on page 40582 in
the Federal Register of Tuesday, July
15, 2008, the following correction is
made:
1. On page 40582, in the third
column, in the headings section of the
document, ‘‘[Docket No. FDA–2007–P–
0326]’’ is corrected to read ‘‘[Docket No.
FDA–2007–P–0300] (formerly 2007P–
0326)’’.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
E:\FR\FM\29JYN1.SGM
29JYN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 146 / Tuesday, July 29, 2008 / Notices
I. Background
FDA is announcing the availability of
a draft information sheet guidance for
sponsors, clinical investigators, and
IRBs entitled ‘‘Frequently Asked
Questions—Statement of Investigator
(Form FDA 1572).’’ This guidance is
intended to assist IRBs, clinical
investigators, and sponsors 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.
It describes how to complete the
Statement of Investigator form (Form
FDA 1572).
FDA developed this draft information
sheet guidance in response to numerous
questions from the research community
regarding Form FDA 1572. In this draft
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 in the Federal
Register of February 3, 2006 (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
new Information Sheet Guidances as
needed.
This draft information sheet guidance
is being issued consistent with FDA’s
GGPs regulation (21 CFR 10.115). The
draft information sheet guidance, when
finalized, will represent the agency’s
current thinking on completing Form
VerDate Aug<31>2005
16:12 Jul 28, 2008
Jkt 214001
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 draft 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) 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. The guidance
and 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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/oc/gcp/draft.html or
https://www.regulations.gov.
Dated: July 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–17305 Filed 7–28–08; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
43941
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 10, 2008, from 8 a.m.
to 5:45 p.m. and on September 11, 2008,
from 8 a.m. to 3 p.m.
Location: Hilton Hotel, Washington,
DC/Rockville Executive Meeting Center,
1750 Rockville Pike, Rockville, MD
20852.
Contact Person: Donald W. Jehn or
Pearline K. Muckelvene, Center for
Biologics Evaluation and Research
(CBER) (HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–0314, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014519516. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On the morning of
September 10, 2008, the Committee will
hear an update on the May 29 to 30,
2008, meeting of the Department of
Health and Human Services Advisory
Committee on Blood Safety and
Availability. Following this update, the
Committee will discuss strategies to
enhance bacterial safety of 7 day
platelets for transfusion. In the
afternoon, the Committee will discuss
iron status in blood donors. On
September 11, 2008, the Committee will
hear updates on the following topics: (1)
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 73, Number 146 (Tuesday, July 29, 2008)]
[Notices]
[Pages 43940-43941]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-17305]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0406]
Draft Information Sheet Guidance for Sponsors, Clinical
Investigators, and Institutional Review Boards on 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 a draft 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 institutional review
boards (IRBs), clinical investigators, and sponsors involved in
clinical investigations of investigational drugs and biologics in
completing the Statement of Investigator form (Form FDA 1572). FDA
developed this draft information sheet guidance in response to numerous
questions from the research community regarding Form FDA 1572. This
draft information sheet guidance provides FDA's responses to the most
frequently asked questions.
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 comments on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft
information sheet guidance by September 29, 2008.
ADDRESSES: Submit written comments on this draft information sheet
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
information sheet guidance document.
FOR FURTHER INFORMATION CONTACT: Patricia M. Beers Block, Office of
Science and Health Coordination/Good Clinical Practice Program (HF-34),
Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857,
301-827-3340.
SUPPLEMENTARY INFORMATION:
[[Page 43941]]
I. Background
FDA is announcing the availability of a draft information sheet
guidance for sponsors, clinical investigators, and IRBs entitled
``Frequently Asked Questions--Statement of Investigator (Form FDA
1572).'' This guidance is intended to assist IRBs, clinical
investigators, and sponsors 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. It describes how to complete the
Statement of Investigator form (Form FDA 1572).
FDA developed this draft information sheet guidance in response to
numerous questions from the research community regarding Form FDA 1572.
In this draft 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 in the Federal Register of February 3,
2006 (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
new Information Sheet Guidances as needed.
This draft information sheet guidance is being issued consistent
with FDA's GGPs regulation (21 CFR 10.115). The draft information sheet
guidance, when finalized, will represent the agency's current thinking
on completing 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 draft 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) 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. The guidance and 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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/oc/gcp/draft.html or https://
www.regulations.gov.
Dated: July 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17305 Filed 7-28-08; 8:45 am]
BILLING CODE 4160-01-S
