[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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