[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
