Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects-Supervisory Responsibilities of Investigators; Availability, 26639 [E7-9055]
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Federal Register / Vol. 72, No. 90 / Thursday, May 10, 2007 / Notices
Dated: May 4, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9056 Filed 5–9–07; 8:45 am]
Path Programs (HF–18), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–7864.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–S
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Protecting the Rights, Safety, and
Welfare of Study Subjects—Supervisory
Responsibilities of Investigators.’’ Under
the regulations in part 312 (21 CFR part
312) (Investigational New Drug
Application) and part 812 (21 CFR part
812) (Investigational Device
Exemptions), an investigator is
responsible for ensuring that a clinical
investigation is conducted according to
the signed investigator statement, the
investigational plan, and applicable
regulations; for protecting the rights,
safety, and welfare of subjects under the
investigator’s care; and for the control of
drugs, biological products, and devices
under investigation (§§ 312.60 and
812.100). This draft guidance clarifies
the responsibilities of investigators in
the conduct of clinical investigations
conducted under parts 312 and 812,
particularly the responsibilities to
supervise the conduct of the clinical
investigation, and to protect the rights,
safety, and welfare of study participants
in drug, biologic, and medical device
clinical trials. The draft guidance also
provides recommendations on how
investigators should supervise the
study-related actions of persons not in
the direct employ of the investigator,
including certain study staff and parties
conducting associated testing and
assessments.
This draft guidance is being issued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The draft guidance, when finalized, will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 the supervisory responsibilities of
investigators. 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D–0173]
Draft Guidance for Industry on
Protecting the Rights, Safety, and
Welfare of Study Subjects—
Supervisory Responsibilities of
Investigators; Availability
AGENCY:
Food and Drug Administration,
HHS.
pwalker on PROD1PC71 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Protecting the Rights,
Safety, and Welfare of Study Subjects—
Supervisory Responsibilities of
Investigators.’’ This draft guidance is
intended to assist investigators in
meeting their responsibilities with
respect to protecting human subjects
and ensuring the integrity of data in the
conduct of clinical investigations. The
draft guidance also clarifies FDA’s
expectations concerning the
investigator’s responsibility for
supervising a clinical study in which
some study tasks are delegated to
employees of the investigator or to
outside parties.
DATES: Submit written or electronic
comments on the draft guidance by July
9, 2007. General comments on agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Critical Path Programs (HF–
18), Office of the Commissioner, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
that office in processing your requests.
Submit telephone requests to 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.fda.gov/dockets/
ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Terrie L. Crescenzi, Office of Critical
VerDate Aug<31>2005
15:04 May 09, 2007
Jkt 211001
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 in part 312 have been
approved under OMB Control No. 0910–
0014; and the collections of information
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
26639
in part 812 have been approved under
OMB Control No. 0910–0078.
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm orhttps://www.fda.gov/ohrms/
dockets/default.htm.
Dated: May 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–9055 Filed 5–9–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, call the HRSA Reports
Clearance Office on (301)–443–1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: Women’s Physical
Activity and Healthy Eating Tools
Assessment: NEW
The HRSA Office of Women’s Health
(OWH) developed the Bright Futures for
Women’s Health and Wellness
(BFWHW) Initiative to help expand the
scope of women’s preventive health
activities, particularly related to
nutrition and physical activity. An
intermediate assessment of the BFWHW
E:\FR\FM\10MYN1.SGM
10MYN1
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[Federal Register Volume 72, Number 90 (Thursday, May 10, 2007)]
[Notices]
[Page 26639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9055]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0173]
Draft Guidance for Industry on Protecting the Rights, Safety, and
Welfare of Study Subjects--Supervisory Responsibilities of
Investigators; 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 ``Protecting the
Rights, Safety, and Welfare of Study Subjects--Supervisory
Responsibilities of Investigators.'' This draft guidance is intended to
assist investigators in meeting their responsibilities with respect to
protecting human subjects and ensuring the integrity of data in the
conduct of clinical investigations. The draft guidance also clarifies
FDA's expectations concerning the investigator's responsibility for
supervising a clinical study in which some study tasks are delegated to
employees of the investigator or to outside parties.
DATES: Submit written or electronic comments on the draft guidance by
July 9, 2007. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Critical Path Programs (HF-18), Office of the
Commissioner, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send one self-addressed adhesive label to assist
that office in processing your requests. Submit telephone requests to
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.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
FOR FURTHER INFORMATION CONTACT: Terrie L. Crescenzi, Office of
Critical Path Programs (HF-18), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7864.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Protecting the Rights, Safety, and Welfare of Study
Subjects--Supervisory Responsibilities of Investigators.'' Under the
regulations in part 312 (21 CFR part 312) (Investigational New Drug
Application) and part 812 (21 CFR part 812) (Investigational Device
Exemptions), an investigator is responsible for ensuring that a
clinical investigation is conducted according to the signed
investigator statement, the investigational plan, and applicable
regulations; for protecting the rights, safety, and welfare of subjects
under the investigator's care; and for the control of drugs, biological
products, and devices under investigation (Sec. Sec. 312.60 and
812.100). This draft guidance clarifies the responsibilities of
investigators in the conduct of clinical investigations conducted under
parts 312 and 812, particularly the responsibilities to supervise the
conduct of the clinical investigation, and to protect the rights,
safety, and welfare of study participants in drug, biologic, and
medical device clinical trials. The draft guidance also provides
recommendations on how investigators should supervise the study-related
actions of persons not in the direct employ of the investigator,
including certain study staff and parties conducting associated testing
and assessments.
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 the
supervisory responsibilities of investigators. 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 in part 312 have been approved under OMB
Control No. 0910-0014; and the collections of information in part 812
have been approved under OMB Control No. 0910-0078.
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.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm orhttps://www.fda.gov/
ohrms/dockets/default.htm.
Dated: May 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9055 Filed 5-9-07; 8:45 am]
BILLING CODE 4160-01-S
