[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Notices]
[Pages 40127-40128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19900]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0049]


Guidance for Industry on Environmental Assessment of Human Drug 
and Biologics Applications; 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 for industry entitled ``Environmental 
Assessment of Human Drug and Biologics Applications.'' This guidance is 
intended to provide information on when an environmental assessment 
(EA) should be submitted in support of a human drug or biologics 
application

[[Page 40128]]

and recommendations on how to prepare EA's.

DATES: Written comments may be submitted at any time.
ADDRESSES: Copies of this guidance for industry are available on the 
Internet at ``http://www.fda.gov/cder/guidance/index.htm'' or ``http://
www.fda.gov/cber/guidelines.htm''. Submit written requests for single 
copies of the guidance to the Drug Information Branch (HFD-210), Center 
for Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857 or Office of Communication, Training 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your requests. Submit written comments 
on the guidance to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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, 301-594-5629, or Daniel C. Kearns, 
Center for Biologics Evaluation and Research (HFM-206), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3031.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Environmental Assessment of Human Drug 
and Biologics Applications.'' The National Environmental Policy Act of 
1969 (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 and 
biologics applications as an integral part of its regulatory process. 
Under the President's reinventing Government initiatives announced in 
April 1995, FDA reevaluated and revised its environmental regulations 
to reduce the number of EA's required to be submitted by industry and, 
consequently, the number of findings of no significant impact prepared 
by the agency under NEPA.
    In the Federal Register of April 3, 1996 (61 FR 14922) (republished 
May 1, 1996 (61 FR 19476)), FDA issued for public comment a notice of 
proposed rulemaking that proposed additional categorical exclusions for 
those actions the Center for Drug Evaluation and Research (CDER) and 
the Center for Biologics Evaluation and Research (CBER) have determined 
normally do not individually or cumulatively have a significant effect 
on the quality of the human environment. The final rule was published 
in the Federal Register of July 29, 1997 (62 FR 40570), and became 
effective August 28, 1997. This guidance is based on the final rule and 
supersedes CDER's ``Guidance for Industry For the Submission of an 
Environmental Assessment in Human Drug Applications and Supplements,'' 
which published in November 1995.
    In the Federal Register of February 12, 1998 (63 FR 7174), FDA 
announced the availability of a draft version of this guidance. The 
February 12, 1998, document gave interested persons an opportunity to 
submit comments through April 13, 1998. All comments received during 
the comment period have been carefully reviewed and incorporated, where 
appropriate, in this revised guidance.
    FDA's regulations in part 25 (21 CFR part 25) specify that 
environmental assessments must be submitted as part of certain new drug 
applications, abbreviated applications, applications for marketing 
approval of a biologic product, supplements to such applications, 
investigational new drug applications and for various other actions 
(see Sec. 25.20), unless the action qualifies for a categorical 
exclusion.
    This guidance provides information on when an EA should be 
submitted and recommendations on how to prepare EA's for submission to 
CDER and CBER for these drug or biologics applications. Topics covered 
include: (1) When categorical exclusions apply, (2) when to submit an 
EA, (3) the content and format of EA's, (4) specific guidance for the 
environmental issues that are most likely to be associated with human 
drugs and biologics, (5) test methods, (6) an applicant's treatment of 
confidential information submitted in support of an EA, and (7) master 
files for drugs and biologics.
    This guidance is a level 1 guidance consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). It represents the 
agency's current thinking on environmental assessment of human drug and 
biologics applications. It does not create or confer any rights for or 
on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirement of the applicable statute, regulations, or both.
    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: July 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19900 Filed 7-24-98; 8:45 am]
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