[Federal Register Volume 63, Number 29 (Thursday, February 12, 1998)]
[Notices]
[Pages 7174-7175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3496]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Draft Guidance for Industry on Environmental Assessment of Human 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Environmental 
Assessment of Human Drug and Biologics Applications.'' This draft 
guidance is intended to provide information on when an environmental 
assessment (EA) should be submitted in support of a human drug or 
biologics application and recommendations on how to prepare EA's.

DATES: Written comments may be submitted on the draft guidance document 
by April 13, 1998. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance for industry entitled ``Environmental Assessment of Human Drug 
and Biologics Applications'' to the Drug Information Branch (HFD-210), 
Center for Drug Evaluation and Research, Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857 or the 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 two self-addressed labels to 
assist that office in processing your request. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 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 
draft guidance and received comments are available for public 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. See the Supplementary Information section for 
electronic access to this document.

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:

I. Background

    FDA is announcing the availability of a draft 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 effects 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 effect 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 on August 28, 1997. This draft guidance is based on the final 
rule and is consistent with the Food and Drug Administration 
Modernization Act of 1997; it is intended to supersede CDER's 
``Guidance for Industry for the Submission of an Environmental 
Assessment in Human Drug Applications and Supplements,'' which 
published in November 1995.
    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) drug 
master files and master files.
    This draft guidance represents the agency's current thinking on the 
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.

 II. Request for Comments

    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). 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 draft guidance and 
received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.

III. Electronic Access

    An electronic version of this draft guidance is available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm or http://
www.fda.gov/cber/cberftp.html.


[[Page 7175]]


    Dated: February 3, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-3496 Filed 2-11-98; 8:45 am]
BILLING CODE 4160-01-F