[Federal Register Volume 62, Number 107 (Wednesday, June 4, 1997)]
[Notices]
[Page 30603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14471]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0189]
Recovery of Investigational New Drugs From Clinical
Investigators; Revised Compliance Policy Guide; Availability
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of revised compliance policy guide (CPG) 7132c.05
entitled, ``Recovery of Investigational New Drugs from Clinical
Investigators.'' Revised CPG 7132c.05 deletes obsolete drug citations
in the Code of Federal Regulations. These references were superseded
under the investigational new drug rewrite (IND Rewrite). Revised CPG
7132c.05 clarifies the terminology used to classify the recovery of
investigational new drugs from clinical investigators consistent with
existing regulations. In addition, consistent with the current CPG,
this policy continues to apply to new animal drugs being studied under
investigational new animal drug applications.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of revised CPG
7132c.05 ``Recovery of Investigational New Drugs from Clinical
Investigators '' (CPG 7132c.05) to the Director, Division of Compliance
Policy (HFC-230), Office of Enforcement, 5600 Fishers Lane, Rockville,
MD 20857. Send one self-addressed adhesive label to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance. Submit written comments on
revised CPG 7132c.05 to the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: JoAnne C. Marrone, Office of
Regulatory Affairs (HFC-230), Food and Drug Administration, 5600
Fishers Lane, Rockville MD 20857, 301-827-1242.
SUPPLEMENTARY INFORMATION:
I. Background
FDA extensively revised its regulations governing the submission
and review of IND's on March 19, 1987. These new regulations, called
the IND Rewrite, were part of FDA's ongoing efforts to improve and
streamline the new drug approval process. There are several provisions
in the regulations that refer to the return of unused supplies to the
sponsor of the IND. This revised CPG is intended to clarify the
terminology to be used when it is necessary to recover investigational
drugs from clinical investigators, consistent with the regulations.
This guidance document represents the agency's current thinking on
the recovery of investigational drugs from clinical 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 statute,
regulations, or both.
II. Request for Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance. Two
copies of any comment are to be submitted, except that individuals may
submit one copy. Comments and requests for copies are to be identified
with the docket number found in brackets in the heading of this
document. A copy of revised CPG 7132c.05 and received comments may be
seen in the office above between 9 a.m. and 4 p.m., Monday through
Friday.
III. Electronic Access
An electronic version of the revised CPG (Chapter 4, Sec. 444.100)
is also available via Internet using the World Wide Web (www) (connect
to the ORA home page at http://www.fda.gov/ora/compliance--
ref/cpg).
Dated: May 27, 1997.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 97-14471 Filed 6-3-97; 8:45 am]
BILLING CODE 4160-01-F
