[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Notices]
[Pages 58694-58695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29486]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0425]
Paclitaxel Drug Products; Environmental Information Needed in New
Drug Applications, Abbreviated New Drug Applications, and
Investigational New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this
document to clarify the environmental information that must be
submitted to the Center for Drug Evaluation and Research (CDER) for
drug products containing paclitaxel. Paclitaxel is an active moiety
that may be obtained or derived from various wild or cultivated species
of yews. Under the National Environmental Policy Act (NEPA), all
Federal agencies are required to assess the environmental impacts of
their actions and to ensure that the interested and affected public is
informed of environmental analyses. This action is being taken to
ensure that environmental factors regarding paclitaxel drug products
are adequately assessed.
FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug
Evaluation and Research (HFD-357), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5721.
SUPPLEMENTARY INFORMATION:
I. Background
NEPA requires all Federal agencies to assess the environmental
impacts of their actions and to ensure that the interested and affected
public is informed of environmental analyses. FDA is required under
NEPA to consider the environmental impacts of approving drug product
applications as an integral part of its regulatory process. FDA's
regulations in 21 CFR part 25 specify that environmental assessments
(EA's) or abbreviated environmental assessments (AEA's) must be
submitted as part of NDA's, antibiotic drug applications, ANDA's,
AADA's, IND's, and for other various actions described under
Sec. 25.22, unless the action qualifies for a categorical exclusion
under Secs. 25.23 and 25.24. FDA's regulations at Sec. 25.23(c) provide
that a person submitting an application for an action that falls within
a class that qualifies for a categorical exclusion shall specify the
provision that excludes the action from the requirement for an EA. FDA
may require an applicant to provide information that establishes to the
agency's satisfaction that the action requested is included within an
excluded category and meets the criteria for the applicable exclusion
(Sec. 25.23(c)). FDA will require an EA for any specific action that
ordinarily is excluded if the agency has sufficient evidence to
establish that the specific proposed action may significantly affect
the quality of the human environment (Sec. 25.23(b)). In the Federal
Register of January 11, 1996 (61 FR 1031), FDA announced the
availability of a CDER guidance document entitled ``Guidance for
Industry for the Submission of an Environmental Assessment in Human
Drug Applications and Supplements'' (Guidance for Industry). The
document was intended to provide guidance on how to prepare EA's for
submission to
[[Page 58695]]
CDER in NDA's, antibiotic drug applications, ANDA's, AADA's, and IND's.
II. Paclitaxel Drug Products
The following clarifies the environmental information that must be
submitted to CDER for drug products containing paclitaxel. For the
purposes of the following discussion, ``applications'' is defined as
IND's that are expected to enroll cumulatively 200 or more subjects,
NDA's, and ANDA's.
In accordance with FDA's NEPA regulations (21 CFR part 25) and the
Guidance for Industry, a person who submits an NDA, ANDA, or IND
involving drug products containing paclitaxel shall include an EA for
the requested action in the applicable format, unless the action
qualifies for a categorical exclusion under Secs. 25.23 and 25.24. In
accordance with Sec. 25.23(c), FDA will require those persons
submitting applications involving drug products containing paclitaxel
derived from natural sources to identify the sources of paclitaxel so
that FDA can determine whether an EA is required.
FDA will treat all applications involving paclitaxel derived from
or otherwise involving Pacific yew trees (Taxus brevifolia) as
requiring the preparation of EA's. Accordingly, FDA will require
persons to prepare and submit to the FDA EA's for applications
involving paclitaxel derived from or otherwise involving the Pacific
yew. The EA's shall, among other things, identify all sources of
Pacific yew which are expected to be harvested in connection with the
manufacture of paclitaxel relating to the application. The EA's shall,
among other things, include a discussion of the anticipated
environmental impacts of such harvests, measures that may be taken to
mitigate adverse impacts, and reasonable alternatives. See in
particular, format items 4, 9, 10 and 11, at Sec. 25.31a. If the
harvest took place prior to the issuance of this Federal Register
notice, the EA's shall discuss, among other things, each such matter
including mitigation measures that are still available. FDA will
require this information in all future applications involving
paclitaxel derived from or otherwise involving the Pacific yew and for
all such applications which have not been finally acted upon by FDA by
November 18, 1976.
FDA will subject such EA's to the NEPA process, and will complete
and issue an EA and finding of no significant impact (FONSI) in
accordance with Secs. 25.32 and 25.42, or an environmental impact
statement (EIS) and record of decision (ROD) in accordance with
Secs. 25.34 and 25.42, as required by NEPA, before approving any NDA or
ANDA involving paclitaxel derived from or otherwise involving the
Pacific yew tree. FDA will also subject such EA's for IND's involving
paclitaxel derived from or otherwise involving the Pacific yew to the
NEPA process, provided that in cases in which the IND involves
treatment of subjects with serious or life-threatening disease, as
determined by the FDA, the FDA, where NEPA permits, will not place the
IND on clinical hold pending the completion of environmental
documentation required by NEPA.
FDA is committed to assuring that assessment of environmental
factors continues throughout the planning process and is integrated
with other program planning at the earliest possible time to ensure
that planning and decisions reflect environmental values (Sec. 25.10).
As provided by FDA regulations under Sec. 25.22(b), ``Failure to submit
an adequate EA, if one is required, . . . is sufficient grounds for FDA
to refuse to file or approve the application or petition.''
EA's, FONSI's, EIS's and ROD's for drug products containing
paclitaxel and other pertinent environmental information relating to
approvals of drug products containing paclitaxel will be filed in
Docket No. 92N-0489. This docket was previously established as a
repository of environmental information relating to the first approval
of a paclitaxel drug product (Taxol, NDA 20-262).
Dated: November 12, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-29486 Filed 11-15-96; 8:45 am]
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