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

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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