[Federal Register Volume 64, Number 45 (Tuesday, March 9, 1999)]
[Rules and Regulations]
[Pages 11376-11377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5681]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 26
[Docket No. 98S-1064]
Implementation of the Mutual Recognition Agreement Between the
United States and the European Community; Pharmaceutical GMP's and
Medical Devices; Establishment of a Public Docket and FDA Contact
Points
AGENCY: Food and Drug Administration, HHS.
ACTION: Establishment of a public docket and FDA contact points.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a public docket for the submission and public
availability of information concerning the implementation of the Mutual
Recognition Agreement (MRA) between the United States and the European
Community (EC) in the areas of pharmaceutical good manufacturing
practices (GMP's) and medical devices. FDA is also establishing contact
points for information covering particular subjects under the MRA
implementation, and the agency is making appropriate information
available on the FDA web site.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written comments to the Dockets Management Branch
[[Page 11377]]
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Documents concerning FDA's implementation of the
MRA are available for public examination in the Dockets Management
Branch.
FOR FURTHER INFORMATION CONTACT:
Pharmaceutical GMP's:
For information regarding human drug GMP's: Brian J. Hasselbalch,
Division of Manufacturing and Product Quality (HFD-325), Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 7520 Standish Pl., Rockville, MD 20855-2737, 301-827-
7285, FAX: 301-594-2202, or E-mail: ``[email protected]''.
For information regarding animal drug GMP's: Judith A. Gushee,
Office of Surveillance and Compliance (HFV-232), Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855-2773, 301-827-0150, FAX: 301-594-1807, or E-mail:
``[email protected]''.
For information regarding human biologic GMP's: Jennifer A. Thomas,
Office of Compliance and Biologics Quality (HFM-600), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-6190, FAX: 301-594-
1944, or E-mail: ``[email protected]''.
Medical Devices:
For information regarding 510(k)'s: Eric J. Rechen, Office of
Device Evaluation (HFZ-402), Center for Devices and Radiological
Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville,
MD 20850, 301-594-2186, FAX: 301-594-2977, or E-mail:
``[email protected]''.
For information regarding device quality systems and GMP's:
Kimberly A. Trautman, Office of Compliance (HFZ-340), Center for
Devices and Radiological Health, Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4646, FAX: 301-594-4672, or
E-mail: ``[email protected]''.
For information regarding third-party program administrative
matters and general MRA issues: John F. Stigi, Division of Small
Manufacturers Assistance (HFZ-220), Office of Health and Industry
Programs, Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-7491,
FAX: 301-443-8818, or E-mail: ``[email protected]''.
SUPPLEMENTARY INFORMATION: On November 6, 1998, FDA published a final
rule in the Federal Register (63 FR 60122) that amended its regulations
under an international agreement between the United States and the EC
by adding part 26 (21 CFR part 26), subparts A through C entitled
``Mutual Recognition of Pharmaceutical Good Manufacturing Practice
Inspection Reports, Medical Device Quality System Audit Reports, and
Certain Medical Device Product Evaluation Reports Between the United
States and the European Community.'' This rule became effective on
December 7, 1998. Under the terms of subpart A of part 26, the
importing country authority may normally endorse pharmaceutical GMP
inspection reports provided by exporting authorities determined to be
equivalent. Under the terms of subpart B of part 26, the importing
country authority may endorse quality system audits performed according
to the importing country authority's requirements and procedures. In
addition, certain medical device product evaluation reports performed
by the exporting country's conformity assessment bodies (CAB's),
according to the importing country authority's requirements and
procedures, may normally be endorsed.
In response to comments on FDA's proposed rule published in the
Federal Register of April 10, 1998 (63 FR 17744), FDA stated that it
plans to make public summaries of key meetings held with its EC
counterparts concerning implementation of the MRA and FDA's regulation,
and that it will make available to the public the administrative file
that constitutes the basis for any of FDA's equivalence determinations
or listings, subject to exemptions from disclosure provided in the
Freedom of Information Act, the Privacy Act, and FDA's regulations (see
comment 1 in section II.C at 60122 at 60127).
Through this notice, FDA is establishing a new docket (Docket No.
98S-1064) in order to make available at a convenient location public
information concerning the implementation of part 26.
Also, in the proposed rule (63 FR 17744), FDA requested (see also
comment 1 in section II.C at 60122 at 60127) that all interested
persons send to FDA information that is: (1) Generally relevant to
implementation of part 26, and (2) of particular relevance to
equivalence criteria described in part 26, Appendix D of subpart A and
their application to authorities listed in Appendix B of subpart A of
part 26. The notice instructed persons to send their information to
docket 98N-0185 (the rulemaking docket).
FDA is particularly interested in obtaining the following types of
information from any interested persons:
(a) Information relevant to determining the equivalence of EC
Member State regulatory authorities that may provide pharmaceutical GMP
inspection reports to FDA under the MRA, and
(b) Information relevant to the assessment procedures of CAB's that
may provide medical device quality system evaluation reports and
certain medical device product evaluation reports to the FDA under the
MRA.
Because FDA desires to separate the administrative record of the
rulemaking for part 26 from the administrative records covering
implementation of part 26, FDA hereby requests that all information
relevant to the implementation of part 26 be sent to the docket
established under this notice (Docket No. 98S-1064). Furthermore, any
information concerning implementation of part 26 and any information
pertaining to the equivalence or listing criteria described previously
that has already been sent to the rulemaking docket will be transferred
to the new docket established for part 26 implementation.
FDA will also make appropriate information concerning the
implementation of the MRA and part 26 available to the public on FDA's
website at ``http://www.fda.gov'' under the ``International'' section.
Dated: March 2, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-5681 Filed 3-8-99; 8:45 am]
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