[Federal Register Volume 61, Number 8 (Thursday, January 11, 1996)]
[Notices]
[Pages 1031-1032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-420]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95D-0375]
Guidance for Industry for the Submission of an Environmental
Assessment in Human Drug Applications and Supplements; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Industry for the
Submission of an Environmental Assessment in Human Drug Applications
and Supplements.'' This document, which was prepared by the Center for
Drug Evaluation and Research (CDER), is intended to provide guidance on
how to prepare environmental assessments (EA's) for submission to CDER
in new drug applications (NDA's), antibiotic applications, abbreviated
new drug applications (ANDA's), abbreviated antibiotic applications
(AADA's), and investigational new drug applications (IND's). The
guidance fulfills a commitment made in the President's National
Performance Report, ``Reinventing Drug and Medical Device
Regulations,'' April 1995, to clarify through guidance current EA
procedures.
DATES: Written comments on the guidance may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the guidance
entitled ``Guidance for Industry for the Submission of an Environmental
Assessment in Human Drug Applications and Supplements'' to the Consumer
Affairs Branch (formerly the CDER Executive Secretariat Staff), Center
for Drug Evaluation and Research (HFD-210), 7500 Standish Pl.,
Rockville, MD 20855. Send two self-addressed adhesive labels to assist
that office in processing your requests. An electronic version of this
guidance is also available via Internet by connecting to the CDER file
transfer protocol (FTP) server (CDVS2.CDER.FDA.GOV) using the FTP.
Submit written comments on the guidance to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. Requests and comments should be identified
with the docket number found in brackets in the heading of this
document. A copy of the guidance and received comments are available
for public examination in the Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug
Evaluation and Research (HFD-357), 5600 Fishers Lane, Rockville, MD
20857, 301-594-6740, FAX 301-594-6197, Internet: [email protected].
SUPPLEMENTARY INFORMATION: 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
impact of approving drug product applications as an integral part
[[Page 1032]]
of its regulatory process. FDA's regulations in part 25 (21 CFR part
25) specify that EA's or abbreviated environmental assessments (AEA's)
must be submitted as part of certain NDA's, antibiotic applications,
ANDA's, AADA's, IND's, and for other various actions. This guidance
provides information on how to prepare EA's for submission to CDER for
these drug product applications. Topics covered in this guidance
include: (1) When categorical exclusions apply, (2) when to submit an
EA or AEA, (3) the content and format of EA's or AEA's, (4) approaches
to determining the environmental fate and effects of substances, (5)
test methods, (6) treatment of confidential information submitted in
support of an EA, (7) special considerations associated with EA's for
genetically altered organisms and materials and products derived from
natural sources, (8) EA documentation for foreign manufacturing
facilities, and (9) drug master files.
CDER encourages industry to implement the use of the content and
format described in this guidance as soon as possible because
standardized documentation submitted by industry increases the
efficiency and speed of the review process. Alternative content and
format styles may be used as long as the regulatory requirements
defined in part 25 are satisfied.
Section III.D.7.c of this guidance describes specific circumstances
(identified as Tier 0) under which format items 7, 8, 9, 10, 11, and 15
are unnecessary and may be omitted from certain environmental
assessments submitted pursuant to Sec. 25.31a(a). Because approval of a
product under these circumstances is unlikely to have a significant
environmental effect, submission of information for these format items
will not ordinarily assist CDER in determining whether an action
significantly affects the environment. Therefore, for applications
already submitted in which these circumstances exist, the applicant has
the option to withdraw the information submitted in format items 7, 8,
9, 10, 11, and 15; and CDER will not review it. The applicant should
submit an amendment to the application stating that the circumstances
described in Tier 0 exist in the application, and the information is
being withdrawn for format items 7, 8, 9, 10, 11, and 15. Because CDER
is required to make the EA and a finding of no significant impact
(FONSI) publicly available, the applicant should provide, along with
the letter, a revised EA with the information in those format items
deleted. The applicant should certify that the remaining information
has not been revised from what was previously submitted. To avoid
unnecessarily complicating the review process if the review has already
been completed, the applicant should state in the letter that it waives
the request to withdraw this information if CDER has prepared a FONSI
based on the previously submitted information. CDER requests that
pending applications be amended on or before February 12, 1996. A copy
of the amendment cover letter should be sent to the contact person
(address above). The applicant has the option of checking with the
contact person regarding the status of the environmental review for its
pending application. An amendment of this type will not affect the user
fee due date required by the Prescription Drug User Fee Act of 1992
(Pub. L. 102-571).
Under the President's reinventing government (REGO) initiatives
announced in April 1995, CDER is reevaluating its environmental
regulations and plans to reduce the number of EA's required to be
submitted by industry and, consequently, the number of FONSI's prepared
by the agency under NEPA. FDA will publish in a future issue of the
Federal Register a proposed rule concerning proposed additional
categorical exclusions for those actions CDER has determined normally
do not individually or cumulatively have a significant effect on the
quality of the human environment. This guidance explaining how to
prepare an EA when required by current regulations will remain in
effect until superseded by revised final regulations or new CDER
guidance.
Although this guidance does not create or confer any rights, for or
on any person, and does not operate to bind FDA, it does represent the
agency's current thinking on how to prepare environmental assessments
for submission to CDER.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance. Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. The guidance and
received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday. -
Dated: January 2, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-420 Filed 1-10-96; 8:45 am]
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