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Dated: May 4, 2007. Path Programs (HF–18), Food and Drug in part 812 have been approved under
Jeffrey Shuren, Administration, 5600 Fishers Lane, OMB Control No. 0910–0078.
Assistant Commissioner for Policy. Rockville, MD 20857, 301–827–7864.
III. Comments
[FR Doc. E7–9056 Filed 5–9–07; 8:45 am] SUPPLEMENTARY INFORMATION:
Interested persons may submit to the
BILLING CODE 4160–01–S I. Background Division of Dockets Management (see
FDA is announcing the availability of ADDRESSES) written or electronic
DEPARTMENT OF HEALTH AND a draft guidance for industry entitled comments regarding this document.
HUMAN SERVICES ‘‘Protecting the Rights, Safety, and Submit a single copy of electronic
Welfare of Study Subjects—Supervisory comments or two paper copies of any
Food and Drug Administration Responsibilities of Investigators.’’ Under mailed comments, except that
the regulations in part 312 (21 CFR part individuals may submit one paper copy.
[Docket No. 2007D–0173]
312) (Investigational New Drug Comments are to be identified with the
Draft Guidance for Industry on Application) and part 812 (21 CFR part docket number found in brackets in the
Protecting the Rights, Safety, and 812) (Investigational Device heading of this document. Received
Welfare of Study Subjects— Exemptions), an investigator is comments may be seen in the Division
Supervisory Responsibilities of responsible for ensuring that a clinical of Dockets Management between 9 a.m.
Investigators; Availability investigation is conducted according to and 4 p.m., Monday through Friday.
the signed investigator statement, the
AGENCY: Food and Drug Administration, investigational plan, and applicable IV. Electronic Access
HHS. regulations; for protecting the rights, Persons with access to the Internet
ACTION: Notice. safety, and welfare of subjects under the may obtain the document at either
investigator’s care; and for the control of http://www.fda.gov/cder/guidance/
SUMMARY: The Food and Drug drugs, biological products, and devices index.htm orhttp://www.fda.gov/ohrms/
Administration (FDA) is announcing the under investigation (§§ 312.60 and dockets/default.htm.
availability of a draft guidance for 812.100). This draft guidance clarifies Dated: May 2, 2007.
industry entitled ‘‘Protecting the Rights, the responsibilities of investigators in Jeffrey Shuren,
Safety, and Welfare of Study Subjects— the conduct of clinical investigations
Assistant Commissioner for Policy.
Supervisory Responsibilities of conducted under parts 312 and 812,
Investigators.’’ This draft guidance is particularly the responsibilities to [FR Doc. E7–9055 Filed 5–9–07; 8:45 am]
intended to assist investigators in supervise the conduct of the clinical BILLING CODE 4160–01–S
ecomments. See the SUPPLEMENTARY the Paperwork Reduction Act of 1995 (BFWHW) Initiative to help expand the
INFORMATION section for electronic (44 U.S.C. 3501–3520). The collections scope of women’s preventive health
access to the draft guidance document. of information in part 312 have been activities, particularly related to
FOR FURTHER INFORMATION CONTACT: approved under OMB Control No. 0910– nutrition and physical activity. An
Terrie L. Crescenzi, Office of Critical 0014; and the collections of information intermediate assessment of the BFWHW
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