[Federal Register: May 10, 2007 (Volume 72, Number 90)]
[Notices]
[Page 26639]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my07-91]
-----------------------------------------------------------------------
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Draft Guidance for Industry on Protecting the Rights, Safety, and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availability of a draft guidance for industry entitled ``Protecting the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 This draft guidance is intended to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 The draft guidance also clarifies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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Critical Path Programs (HF-18), Office of the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 Submit written comments on the draft
guidance to the Division of Dockets Management (HFA-305), Food and Drug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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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draft guidance document.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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm orhttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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