In the Federal Register of January 12, 2000 (65FR1776), the Food and Drug Administration (FDA) published a final rule removing the provision for submitting Type I drug master files (DMFs). This rule is intended to eliminate submissions of information that are not necessary either to conduct inspections of manufacturing facilities or to review the chemistry, manufacturing, and controls sections of Investigational New Drug Applications (INDs), New Drug Appliations, and abbreviated applications. The agency will no longer accept Type I DMFs or correspondence updating existing Type I DMFs.
The Center for Biologics Evaluation and Research (CBER) believes that for certain biological products, such as gene therapy products, review of some information that has previously been submitted in Type I DMFs is necessary to assess their safety for use in clinical trials under IND. CBER will accept this information for such products in Type V Master Files. On July 10, 2000, the effective date of this final rule, CBER intends to administratively recategorize current Type I Master Files that are still needed to other Master File Types as appropriate. Applicants who have current approved applications that reference Type I DMFs transferred to Type V DMFs may notify the agency of this change in an annual report as provided in 21 CFR 601.12.
Below is a table containing the tracking number (BBIND), and name and address of the sponsor for those Type I Master Files that CBER does not intend to recategorize and will close. If a holder of a Type I Master File believes that the Master File should be recategorized, the holder may contact the Division of Manufacturing and Product Quality (DMPQ) (HFM-207), Office of Compliance and Biologics Quality, CBER, 1401 Rockville Pike, Rockville, MD 20852-1448. DMPQ may also be reached at 301-827-3031.
Type 1 Master Files to be Closed Effective July 10, 2000
BBIND |
SPONSOR |
81 |
Parke-Davis Warner Lambert Pharmaceutical Research Div
170 Tabor Rd,
Morris Plains, NJ
07950 |
279 |
SKF
1250 S. Collegeville Rd.
Collegeville, PA
19426-0989 |
1107 |
Beecham
Executive Offices
501 5th Street
Bristo, TN
37620 |
1532 |
Hoffmann-La Roche, Inc
340 Kingsland Street
Nutley, NJ
07110-1199 |
1585 |
Genentech, Incorporated
1 DNA Way
South San Francisco, CA
94080-4990 |
1631 |
AMF
Morehead Patterson Center
689 Hope Street
Stamford, CT
060907 |
1671 |
Parke-Davis Warner Lambert Pharmaceutical Research Div
170 Tabor Rd
Morris Plains, NJ
07950 |
2021 |
Ventrex
217 Read Street
P.O. Box 9731
Portland, ME
04104-5031 |
2149 |
Revlon Health
Rorer Pharmaceutical Corporation
500 Washington Drive
Fort Washington, PA
10934 |
2238 |
Karyon Technology
Charles River Biotechnical Services, Inc
251 Ballardvale Street
Wilmington, MA
01887 |
2598 |
Pharmacia & Upjohn
7000 Portage Road
Kalamazoo, MI
49001-0199 |
2714 |
Chas River Biotech
251 Ballardvale Street
Wilmington, MA
01887 |
2976 |
Dupont
Diagnostic Imaging Division
331 Treble Cove Road
North Biullerica, MA
01862 |
3148 |
Osterreichisches
Institut Fur Haemoderivate Ges. M.B.H.
Industriestrasse 67
A-1220 Vienna
Austria |
3220 |
Fresenius Medical Care, North American
Two Ledgemont Center
95 Hayden Avenue
Lexington, MA
02420 |
3225 |
Stolle Research
2964 Street
Route 42 South
Lebanon, OH
45036 |
3255 |
Hoffmann-Laroche, Inc
340 Kingsland Street
Nutley, NJ
07110-1199 |
3381 |
Oros Instruments
715 Banbury Avenue
Slough, SL 41J
United Kingdom |
4183 |
Sandoz Ltd
Pharmaceutical Division
CH-4002
Basle, Switzerland |
4479 |
Charles River Div of Wilmington Partners LP
251 Ballardvale Street
Wilmington, MA
01887 |
4830 |
Gensia Labs, Ltd
19 Hughes
Irvine, CA
92718-1902 |
5339 |
Bachem California
3132 Kashiwa Street
Torrance, CA
90505 |
5644 |
Merck Frosst Canada Inc
P.O. Box 1005
Pointe-Claire-Dorval
Quebec, H9R 4P8
Canada |
5655 |
Unisyn Technologies, Inc
25 South Street, Suite E
Hopkinton, MA
01748 |
5717 |
Nutritional Products Group, New Zealand Dairy Board
Nutritional Products Group
25 The Terrace
P O Box 417
Wellington
New Zealand |
5719 |
Nutritional Products Group, New Zealand Dairy Board
Nutritional Products Group
25 The Terrace
P O Box 417
Wellington
New Zealand |
5720 |
Nutritional Products Group, New Zealand Dairy Board
Nutritional Products Group
25 The Terrace
P O Box 417
Wellington
New Zealand |
5721 |
Nutritional Products Group, New Zealand Dairy Board
Nutritional Products Group
25 The Terrace
P O Box 417
Wellington
New Zealand |
7126 |
Q-One Biotech Ltd
Todd Campus
West of Scotland Science Park
Glasgow, G20 OXA
UK |
FOR FURTHER INFORMATION CONTACT:
Robert A. Yetter
Center for Biologics Evaluation and Research (HFM-10),
Food and Drug Administration,
1401 Rockville Pike, Rockville, MD 20852-1448,
301-827-0373
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