[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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