[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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]
BILLING CODE 4160-01-F