[Federal Register Volume 60, Number 118 (Tuesday, June 20, 1995)]
[Notices]
[Page 32159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14948]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95D-0115]


Compliance Policy Guides Manual; Availability

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a new bound edition of the ``FDA Compliance Policy 
Guides'' (CPG manual). The CPG manual is intended to provide guidance 
to FDA district offices by offering a convenient and organized system 
for statements of FDA compliance policy, including those statements 
which contain regulatory action guidance information.

ADDRESSES: The CPG manual may be ordered from National Technical 
Information Service (NTIS), U.S. Department of Commerce, 5285 Port 
Royal Rd., Springfield, VA 22161. Orders must reference NTIS order 
number PB95-915499 for each copy of the manual. Payment may be made by 
check, moneyorder, charge card (American Express, VISA, or Mastercard), 
or billing arrangements made with NTIS. Charge card orders must include 
the charge card account number and expiration date. For telephone 
orders or further information on placing an order, call NTIS at 703-
487-4650. The CPG manual is available for public examination in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Barbara A. Rodgers, Office of 
Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-0417.

SUPPLEMENTARY INFORMATION: FDA is issuing the new bound edition of the 
CPG manual to provide information on FDA compliance policy and internal 
guidance to FDA district offices in a more organized, convenient, and 
economical format. With the publication of this bound edition, the CPG 
manual has been reorganized into a general chapter and five program 
area chapters. The new CPG manual contains 500 individual guides; 227 
of these have been revised and/or updated, and 26 of the guides have 
been deleted. This new bound edition of CPG's does not contain chapters 
55 through 58, which contained memoranda of understanding (MOU's), 
interagency agreements (IAG's), and mutual recognition agreements 
(MRA's).
    The statements made in the CPG manual are not intended to create or 
confer any rights, privileges, or benefits on or for any private 
person, but are intended merely for internal FDA guidance.

    Dated: June 13, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-14948 Filed 6-19-95; 8:45 am]
BILLING CODE 4160-01-F