[Federal Register Volume 61, Number 203 (Friday, October 18, 1996)]
[Notices]
[Pages 54448-54449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-26914]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95S-0181]


Mutual Recognition Agreement (MRA); Public Meeting; Availability

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and availability of draft document.

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SUMMARY: The Food and Drug Administration (FDA) (Office of External 
Affairs, Office of International Affairs; Office of Policy; Office of 
Operations, Office of Regulatory Affairs; and the Centers for Biologics 
Evaluation and Research, Drug Evaluation and Research, and Veterinary 
Medicine) is announcing a public meeting to provide information about 
discussions with the European Union (EU) related to a possible 
agreement to exchange inspectional information on good manufacturing 
practices and quality controls for human biologicals and human and 
animal drugs. At a meeting held on March 31, 1995, FDA committed to 
keeping the public informed about the progress of these negotiations 
and to receiving comments on FDA's proposal for an MRA. FDA is also 
announcing the availability of the document entitled ``FDA Proposal for 
an Agreement With the European Union Concerning the Mutual Recognition 
of Inspections to Determine Adherence to Good Manufacturing Practices 
for Pharmaceuticals Including Biologicals.''

DATES: The public meeting will be held on Wednesday, October 30, 1996, 
from 9 a.m. to 1 p.m. Those persons interested in attending this 
meeting must fax their registration, including name(s), firm/
organization name, address, and telephone and fax number by October 25, 
1996, to Nathaniel L. Geary (address below). Those persons interested 
in making a presentation at this meeting must contact Nathaniel L. 
Geary (address below) by October 25, 1996. There is no registration fee 
for this meeting, but advance registration is required. Space is 
limited and all interested parties are encouraged to register early. 
Written comments may be submitted at any time.

ADDRESSES: The public meeting will be held at the Parklawn Bldg., 
conference room E, 5600 Fishers Lane, Rockville, MD 20857.
    Submit written requests for single copies of ``FDA Proposal for an 
Agreement With the European Union Concerning the Mutual Recognition of 
Inspections to Determine Adherence to Good Manufacturing Practices for 
Pharmaceuticals Including Biologicals'' to Walter M. Batts or Merton V. 
Smith (address below). Send two self-addressed adhesive labels to 
assist that office in processing your requests. Submit written comments 
on ``FDA Proposal for an Agreement With the European Union Concerning 
the Mutual Recognition of Inspections to Determine Adherence to Good 
Manufacturing Practices for Pharmaceuticals Including Biologicals'' to 
Merton V. Smith (address below). Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. A copy of ``FDA Proposal for an Agreement with the 
European Union Concerning the Mutual Recognition of Inspections to 
Determine Adherence to Good Manufacturing Practices for Pharmaceuticals 
Including Biologicals'' and received comments may be seen at the 
Dockets Management Branch between 9 a.m and 4 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: 
    For information regarding registration: Nathaniel L. Geary, 
Industry and Small Business Liaison Staff (HF-50), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3375, 
FAX 301-443-5153.
    For information regarding comments: Walter M. Batts or Merton V. 
Smith, Office of International Affairs (HFG-1), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480, 
FAX 301-443-0235.

SUPPLEMENTARY INFORMATION: Joint discussions between the U.S. 
Department of Agriculture, Animal and Plant Health Inspection Service, 
and the FDA with the EU, were disclosed in a public meeting held in 
Washington, DC on March 31, 1995. FDA is interested in the views of 
industry and other interested parties on its approach to negotiating an 
MRA with the EU. It would be useful for FDA to receive comments on the 
following issues: What effect will such an agreement have upon 
importation and exportation of those drug and biological products which 
would be covered by an MRA? What effect on product safety or other 
product-related matters, if any, do industry and other interested 
parties perceive to result from entering into an MRA?

[[Page 54449]]

    Interested persons may submit written comments on ``FDA Proposal 
for an Agreement With the European Union Concerning the Mutual 
Recognition of Inspections to Determine Adherence to Good Manufacturing 
Practices for Pharmaceuticals Including Biologicals'' to Merton V. 
Smith (address above). Two copies of any comments are to be submitted, 
except that individuals may submit one copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. A copy of ``FDA Proposal for an Agreement With the 
European Union Concerning the Mutual Recognition of Inspections to 
Determine Adherence to Good Manufacturing Practices for Pharmaceuticals 
Including Biologicals'' and received comments may be seen at the 
Dockets Management Branch (address above) between 9 a.m. and 4 p.m.

    Dated: October 16, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-26914 Filed 10-17-96; 8:45 am]
BILLING CODE 4160-01-F