[Federal Register Volume 61, Number 172 (Wednesday, September 4, 1996)]
[Notices]
[Pages 46664-46666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22496]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 95-41]
Johnson Matthey, Inc.; Termination of Proceedings
On May 8, 1995, the Deputy Administrator of the Drug Enforcement
Administration (DEA) issued a final order granting the September 14,
1992, application of Johnson Matthey, Inc. (Johnson Matthey) to
register as a bulk manufacturer of methylphenidate, subject to certain
conditions. (Johnson Matthey I) 60 FR 26050 (May 16, 1995). On January
2, 1996, the United States Court of Appeals for the District of
Columbia Circuit denied a petition for review of that final order. MD
Pharmaceutical, Inc. v. Drug Enforcement Administration, Docket No. 95-
1267, 1996 U.S. App. Lexis 1229 (D.C. Cir. 1996).
In the meantime, on February 24, 1995, Johnson Matthey filed an
application for calendar year 1995 for registration as a bulk
manufacturer of various Schedule I and II controlled substances,
including methylphenidate, notice of which was filed in the Federal
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Register. 60 FR 20751 (April 27, 1995). However, on July 27, 1995,
Johnson Matthey withdrew its application, except as to methylphenidate.
See 60 FR 53804 (October 17, 1995). Therefore, the only aspects of
Johnson Matthey's February 1995 application pending is the request to
manufacture methylphenidate. By letter dated May 10, 1995, MD
Pharmaceutical, Inc. (MD) filed comments, objecting to Johnson
Matthey's application with respect to methylphenidate, and by letter
dated May 26, 1995, Ciba-Geigy Corporation (Ciba) requested a hearing,
giving rise to the instant case.
Also by letter dated May 26, 1995, Mallinckrodt Chemical, Inc.
(Mallinckrodt), stated that it took no position on Johnson Matthey's
application to manufacture methylphenidate, but that it ``wish[ed] to
participate fully in a hearing if one is scheduled.'' The matter was
docketed and assigned to Administrative Law Judge Mary Ellen Bittner.
Extensive prehearing communications followed, with the Government
filing its prehearing memorandum on July 28, 1995, and Johnson Matthey,
Ciba, Mallinckrodt, and MD filing their prehearing memoranda on July
31, 1995. Again, the parties engaged in extensive prehearing filings
surrounding the issue of whether to hold in abeyance a hearing in this
matter pending the decision of the Court of Appeals in Johnson Matthey
I.
Subsequently, on October 17, 1995, the DEA published a notice in
the Federal Register, stating, among other things, that ``[d]ue to the
pending administrative proceeding concerning methylphenidate, Johnson
Matthey will continue on a day-to-day registration to bulk manufacture
methylphenidate pending resolution of Docket No. 95-41.'' 60 FR 53804
(1995). On November 13, 1995, Johnson Matthey filed an application to
be registered as a bulk manufacturer of various controlled substances,
including methylphenidate, for calendar year 1996. See Notice of
Application, 61 FR 8303 (March 4, 1996).
Following the circuit court's decision in Johnson Matthey I, on
February 23, 1996, Johnson Matthey filed a motion to dismiss, or in the
alternative to terminate, the current proceeding. On March 14, 1996,
the Government filed a Motion for Summary Disposition, seeking
dismissal of this proceeding on various grounds. On March 18, 1996, MD
filed an Objection to Johnson Matthey's Motion to Dismiss, and Ciba
filed a Memorandum in Response to Motion of Johnson Matthey, Inc., to
Dismiss and Government's Motion for Summary Disposition. Also, on March
19, 1996, Mallinckrodt filed a Response to Johnson Matthey's Motion to
Dismiss, and on April 8, 1996, MD filed an Opposition to the
Government's Motion for Summary Disposition.
By order dated May 15, 1996, Judge Bittner (1) denied the
Government's motion for summary disposition, (2) denied Johnson
Matthey's motion to dismiss, (3) found, however, that there was no
longer a basis for holding a hearing in this proceeding, and (4)
terminated the proceeding. She afforded the parties an opportunity to
file an appeal from her ruling, and on June 3, 1996, the Government
filed exceptions to her ruling, but agreed with her termination of the
proceedings. No other appeals were filed.
The Deputy Administrator finds that as of May 8, 1995, Johnson
Matthey had a Certificate of Registration as a bulk manufacturer of
methylphenidate. See Johnson Matthey I. As noted by Judge Bittner, both
the Administrative Procedure Act and DEA's regulations provide that a
timely application for reregistration operates to continue an existing
registration until there is a determination on that application. 5
U.S.C. Sec. 558(c)\1\ and 21 C.F.R. 1301.47.\2\ Therefore, the Deputy
Administrator agrees with Judge Bittner's findings that (1) the
November 1995 application for reregistration operates to continue
Johnson Matthey's registration granted by final order on May 8, 1995,
with respect to methylphenidate, (2) Johnson Matthey's reregistration
cannot be denied until DEA takes further action,\3\ and (3) the
November 1995 application is not before Judge Bittner (nor the Deputy
Administrator) as a result of Ciba's hearing request relevant to the
February 1995 application. See 60 FR 32099 (June 30, 1995) (amending 21
C.F.R. 1301.43, effective July 20, 1995, by eliminating third-party
manufacturers' hearing opportunities, pursuant to their own request).
The Deputy Administrator also finds that the termination of these
proceedings will not impact upon the continuation of Johnson Matthey's
day-to-day registration to manufacture methylphenidate, given the lack
of a resolution of its pending November 1995 application.
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\1\ 5 U.S.C. Sec. 558(c) states: ``When the licensee has made
timely and sufficient application for a renewal or a new license in
accordance with agency rules, a license with reference to an
activity of a continuing nature does not expire until the
application has been finally determined by the agency.''
\2\ 21 C.F.R. 1301.47 provides: ``In the event that an applicant
for reregistration (who is doing business under a registration
previously granted and not revoked or suspended) has applied for
reregistration at least 45 days before the date on which the
existing registration is due to expire, and the Administrator has
issued no order on the application on the date on which the existing
registration is due to expire, the existing registration of the
applicant shall automatically be extended and continue in effect
until the date on which the Administrator so issues his order.''
\3\ 21 U.S.C. Sec. 824(c) provides, in relevant part, that
``[b]efore taking action pursuant * * * to a denial of registration
under section 823 of this title, the Attorney General shall serve
upon the applicant or registrant an order to show cause why
registration should not be denied. * * *''
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The Deputy Administrator agrees with Judge Bittner's termination of
the hearing procedure raised by Ciba's request in response to Johnson
Matthey's registration application of February 1995. As Judge Bittner
noted, ``if a hearing were held in this proceeding, whatever
recommendation [she] would make with respect to Johnson Matthey's
[February] 1995 application would be of no consequence.'' If Judge
Bittner recommended granting the February 1995 application, she would
be recommending Johnson Matthey be given a right already flowing from
the May 1995 final order and the November 1995 reregistration
application. If, however, Judge Bittner recommended the application be
denied, and if the Deputy Administrator concurred with that
recommendation, a show cause proceeding would need to be instigated.
See 21 U.S.C. Sec. 824(c), quoted at footnote 3 supra. Therefore, since
the hearing will have no impact upon Johnson Matthey's registration at
this point in the registration process, the Deputy Administrator
concurs with Judge Bittner's decision to terminate this proceeding.
See, e.g., National Classification Comm. & Natl. Motor Freight Traffic
Assn., Inc. v. United States, 779 F.2d 687, 693 (D.C. Cir. 1985)
(noting that ``a hearing is required only when it would serve some
purpose'').
Judge Bittner made findings necessary to resolve the Government's
Motion for Summary Disposition and Johnson Matthey's Motion to Dismiss.
The Deputy Administrator has reviewed those findings, Judge Bittner's
resolution of the two motions, and the Government's exceptions thereto.
However, the Deputy Administrator concludes that it is unnecessary to
address those matters here, since they do not impact upon the propriety
of the termination decision. Therefore, the Deputy Administrator makes
no findings concerning those issues.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823, and 28 C.F.R. 0.100(b) and 0.104,
[[Page 46666]]
hereby orders that the request for a hearing concerning Johnson
Matthey's February 1995 registration application, and the proceedings
following and relevant to that request be, and they hereby are,
terminated.
This order is effective October 4, 1996.
Dated: August 27, 1996.
Stephen H. Greene,
Deputy Administrator
[FR Doc. 96-22496 Filed 9-3-96; 8:45 am]
BILLING CODE 4410-09-M