[Federal Register Volume 61, Number 205 (Tuesday, October 22, 1996)]
[Proposed Rules]
[Pages 54746-54747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Part 25

[Docket No. 96N-0057]


National Environmental Policy Act; Proposed Revision of Policies 
and Procedures; Reopening of Comment Period as to Specific Documents

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening to 
November 22, 1996, the comment period on specific information that 
supports certain categorical exclusions proposed by FDA in the proposed 
rule entitled ``National Environmental Policy Act; Proposed Revision of 
Policies and Procedures.'' The proposal was published in the Federal 
Register of April 3, 1996 (61 FR 14922) (republished on May 1, 1996 (61 
FR 19476)). FDA is reopening the comment period for 30 days for the 
sole purpose of inviting public comments on those categorical 
exclusions for which information has been added to the administrative 
record.

DATES: Written comments must be received by or postmarked on or before 
November 21, 1996. Comments postmarked after such date will not be 
considered.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: 
    For information regarding human drugs: Nancy B. Sager, Center for 
Drug Evaluation and Research (HFD-357), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-594-5721.
    For information regarding biologics: Nancy A. Roscioli, Center for 
Biologics Evaluation and Research (HFM-205), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3031.
    For information regarding veterinary medicines: Charles E. Eirkson, 
Center for Veterinary Medicine (HFV-150), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 301-594-1683.
    For information regarding foods: Buzz L. Hoffmann, Center for Food 
Safety and Applied Nutrition (HFS-246), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3005.
    For information regarding medical devices and radiological health: 
Mervin O. Parker, Center for Devices and Radiological Health (HFZ-402), 
Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 
20850, 301-594-2186.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 3, 1996 (61 
FR 14922) (republished on May 1, 1996 (61 FR 19476)), FDA published a 
proposed rule to amend its regulations governing compliance with the 
National Environmental Policy Act of 1969 (NEPA) as implemented by the 
regulations of the Council on Environmental Quality. The primary 
purpose of the proposed rule is to increase the efficiency of FDA's 
implementation of NEPA and reduce the number of NEPA evaluations by 
providing for categorical exclusions for additional classes of actions 
that do not individually or cumulatively have a significant effect on 
the human environment and for which, therefore, neither an 
environmental impact statement nor an environmental assessment (EA) is 
required. The proposed rule was issued in response to an initiative 
announced in the President's National Performance Reports, 
``Reinventing Drug and Medical Device Regulations,'' April 1995, and 
``Reinventing Food Regulations,'' January 1996. The proposal gave 
interested persons the opportunity to submit written comments until 
July 2, 1996.
    One of the categorical exclusions included in the proposed rule is 
a categorical exclusion for an ``[a]ction on an NDA [new drug 
application], abbreviated application, or a supplement to such 
application, or action on an OTC [over-the-counter] monograph, if the 
action increases the use of the active moiety, but the concentration of 
the substance in the environment will be below 1 part per billion 
[ppb].'' (See proposed Sec. 25.31(b) (61 FR 19476 at 19492).) The 
agency proposed this categorical exclusion because FDA has determined 
that such actions for which concentrations of the substance in the 
environment from use and disposal will be below 1 ppb ordinarily do not 
have a significant effect on the environment. If there are specific 
environmental concerns beyond those relating to use and disposal, for 
example sourcing, FDA may give a specific action further environmental 
consideration.
    On July 2, 1996, FDA received a request from Edward Lee Rogers, on 
behalf of the Oregon Natural Resources Council Fund and the Oregon 
Natural Resources Council Action, to extend the comment period to 
permit comment on the ``underlying data upon which FDA relies for the 
claimed adequacy and appropriateness of that [1 ppb] criteria.''
    FDA considered this request and has decided to add information to 
the administrative record and reopen the comment period. FDA has added 
to the administrative record a report on the ``Retrospective Review of 
Ecotoxicity Data Submitted in Environmental Assessments.'' This report 
summarizes the ecotoxicity data that supports the Center for Drug 
Evaluation and Research's (CDER's) proposal to categorically exclude 
actions on an NDA, abbreviated application, or a supplement to such 
application, or action on an OTC monograph, if the action increases the 
use of the active moiety, but the concentration of the substance in the 
environment will be below 1 ppb. FDA has also added to the 
administrative record an index of the petitions and actions that 
support certain categorical exclusions for foods,

[[Page 54747]]

food additives and color additives in the proposed rule.
    The agency is reopening the comment period to ensure that the 
public has an opportunity to comment on the data that support the 
proposed categorical exclusions set forth in Secs. 25.31(b) and 
25.32(i), (j), (k), (l), (m), (q), and (r).
    FDA believes that 30 days to comment is ample in this case, because 
the agency is specifically limiting its reopening of the comment period 
to comments on the categorical exclusions for which information has 
been added to the administrative record. Furthermore, data from EA's 
and findings of no significant impact for approved applications that 
support FDA's proposed categorical exclusions have always been 
available to the public upon request. Comments are invited, and will be 
considered, only to the extent they are focused on the categorical 
exclusions supported by information that has been added to the 
administrative record and only to the extent the comments regarding 
such information raise new issues not already raised by the person 
submitting the comment.
    The documents that the agency is adding to the record are as 
follows:
    1. ``Retrospective Review of Ecotoxicity Data Submitted in 
Environmental Assessments,'' CDER, FDA.
    2. Index of Petitions and Actions Supporting Categorical Exclusions 
for Foods, Food Additives, and Color Additives in proposed 21 CFR part 
25.
    Interested persons may, on or before November 21, 1996, submit to 
the Dockets Management Branch (address above) written comments 
regarding the documents listed 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. Received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 16, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-27022 Filed 10-21-96; 8:45 am]
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