Guidance for Industry on Environmental Assessment of Human Drug and Biologics Applications; Availability

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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