[Federal Register Volume 64, Number 89 (Monday, May 10, 1999)]
[Notices]
[Page 25046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11583]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-1069]
Changes in the Procedures for Providing Public Notice of the
Availability of Completed Environmental Assessments and Findings of No
Significant Impact
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER), is announcing changes in the procedures
used for providing public notice of the availability of completed
environmental assessments (EA's) and findings of no significant impact
(FONSI's) for new drug applications (NDA's), abbreviated new drug
applications (ANDA's), and supplemental applications.
Effective Date: May 10, 1999.
ADDRESSES: Copies of EA's and FONSI's are available on the Internet at
``http://www.fda.gov.cder/foi/index.htm'' or may be requested by
writing the Freedom of Information Staff (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857.
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, 301-594-5633.
SUPPLEMENTARY INFORMATION: Under the National Environmental Policy Act
of 1969 (NEPA), Congress declared that it will be the continuing policy
of the Federal Government to ``use all practicable means and measures,
including financial and technical assistance, in a manner calculated to
foster and promote the general welfare, to create and maintain
conditions under which man and nature can exist in productive harmony,
and fulfill the social, economic, and other requirements of present and
future generations of Americans.'' (See 42 U.S.C. 4331(a).) NEPA
requires all Federal agencies to include in every recommendation or
report for major Federal actions significantly affecting the quality of
the human environment a detailed statement assessing the environmental
impact of, and alternatives to, the proposed action and to make
available to the public such statements. (See 42 U.S.C. 4332 and 40 CFR
1506.6.)
FDA regulations in part 25 (21 CFR part 25) govern compliance with
NEPA, as implemented by the regulations of the Council on Environmental
Quality (CEQ) in 40 CFR part 1500. Under FDA regulations, actions to
approve NDA's, ANDA's, and supplements to existing approvals ordinarily
require the preparation of an EA. (See Sec. 25.20(l).)
In accordance with FDA regulations, FDA must make completed EA's
and FONSI's for NDA's, ANDA's, and supplements available to the public
upon request in accordance with the procedures in 40 CFR 1506.6. (See
Sec. 25.51(b)(2).) The regulations at 40 CFR 1506.6 require that
certain environmental documents be made available to the public under
the provisions of the Freedom of Information Act (5 U.S.C. 552) and
that these documents be made available to the public without charge, to
the extent practicable. (See 40 CFR 1506.6(f).) This is the procedure
used by CDER to provide completed EA's and FONSI's for NDA's, ANDA's,
and supplements for human drugs to the public when they are requested.
Although not required by regulation, CDER has also periodically
published notices in the Federal Register (57 FR 18887, 61 FR 49470, 62
FR 22960, 63 FR 27300) that provide a listing of EA's and FONSI's that
are available for NDA's, ANDA's, and supplements. FDA is announcing
that CDER will no longer publish such notices, because the
environmental documents are now available on the Internet.
In 1996, FDA established the Center for Drug Evaluation and
Research (CDER) Freedom of Information Office Electronic Reading Room,
which can be accessed through the Internet at ``http://
www.fda.gov.cder/foi/index.htm''. The electronic reading room provides
a listing of applications approved by CDER and electronic copies of
agency documents used to support the approval of the applications under
the heading ``Drug Approval Packages.'' The agency documents include an
EA and FONSI for each application unless the action was categorically
excluded from the requirement to prepare an EA. (See Sec. 25.31.)
Publication of a notice in the Federal Register announcing the
availability of completed EA's and FONSI's for NDA's, ANDA's, and
supplements duplicates the information available through the CDER
Freedom of Information Office Electronic Reading Room. Therefore, to
promote efficient operations, FDA will discontinue publication of such
Federal Register notices, effective immediately.
Dated: April 30, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-11583 Filed 5-7-99; 8:45 am]
BILLING CODE 4160-01-F
