[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Page 11018-11019]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003D-0379]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Preparing a Claim of 
Categorical Exclusion or an Environmental Assessment for Submission to 
the Center for Food Safety and Applied Nutrition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by April 
8, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
Preparing a Claim of Categorical Exclusion or an Environmental 
Assessment for Submission to the Center for Food Safety and Applied 
    FDA's regulation in 21 CFR 25.20 specifies the types of actions 
related to food additive petitions, color additive petitions, requests 
for exemption from regulation as a food additive under Sec.  170.39 (21 
CFR 170.39), notifications for food contact substances under section 
409(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
348(h)), generally recognized as safe (GRAS) affirmation petitions, and 
citizen petitions for certain food labeling regulations that require at 

[[Page 11019]]

the preparation of an environmental assessment (EA), unless the action 
qualifies for a categorical exclusion under 21 CFR 25.30 or 25.32. 
FDA's regulations in part 25 (21 CFR part 25) are based upon the 
requirements of the National Environmental Policy Act (NEPA) (42 U.S.C. 
4321 et seq.). The agency's collection of information on food additives 
and food-contact substances is based upon the requirements in section 
409 of the act. Likewise, section 721 of the act (21 U.S.C. 379(e)) 
provides for the collection of information on color additives. The 
submission to FDA by interested parties of a GRAS affirmation petition 
is voluntary. The information to be submitted with a GRAS affirmation 
petition is listed in Sec. 170.35 (21 CFR 170.35), including, in Sec.  
170.35(c)(1)(viii), the environmental information to be submitted. The 
environmental information to be submitted with petitions for certain 
food labeling regulations is listed in 21 CFR 101.12(h)(12) and 
101.69(h) and in paragraph F of the form for petitions for a health 
claim in 21 CFR 101.70(f).
    Thus, FDA collects information on the potential for environmental 
impacts of its actions in the form of environmental assessments and 
claims for categorical exclusions from interested parties who request 
agency action by submitting to the agency any of the above listed 
petitions, requests for exemption, or food contact substance 
notifications. After this information has been collected, the agency 
will use it to determine whether its action may significantly affect 
the quality of the human environment.
    FDA has collected information from interested parties requesting 
agency action for many years. Over the years, this collected 
information has taken several different forms. The agency amended its 
environmental regulations in the 1997 rule to 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 affect on the quality of the human environment. In the 1997 
rule, FDA also removed the formats for EAs from its regulations and, 
instead, now directs interested parties to the agency's centers for 
information on what is needed in EAs. This draft guidance is FDA's 
current thinking on what information is needed for the environmental 
documentation of the actions that are most often requested. The draft 
guidance contains requests for certain information that has not been 
requested routinely in the past. FDA is now requesting that submitters 
provide certain information to support their claims that the 
categorical exclusions listed in Sec. 25.32(i), (o), and (q) will be 
applicable to their requested actions. Since these informational 
requests are new, FDA is requesting approval from OMB for this 
collection of information. The remainder of the environmental 
information requests are covered by the information collection 
approvals for the underlying actions, i.e., the OMB control number for 
food additive petitions is 0910-0016; for color additive petitions, 
0910-0185; for requests for exemption from regulation as a food 
additive under Sec.  170.39, 0910-0298; for notifications for food 
contact substances, 0910-0480; for GRAS affirmation petitions, 0910-
0132; and for petitions for food labeling regulations, 0910-0183.
    Description of Respondents: The likely respondents include 
businesses engaged in the manufacture or sale of food, food 
ingredients, and substances used in materials that come into contact 
with food.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                       Annual Frequency
             21 CFR Section                   No. of Respondents         per Response      Total Annual Responses  Hours per Response     Total Hours
25.32(i)                                                       68                     2                    136                     1              136
25.32(o)                                                        1                     1                      1                     1                1
25.32(q)                                                        5                     2                     10                     1               10
Total                                     ..........................  ..................  .......................  ..................             147
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The above estimates for respondents and numbers of responses are 
based on the annualized numbers of petitions and notifications 
qualifying for Sec. 25.32(i) and (q) that the agency has received since 
its environmental regulations were amended to include additional 
categorical exclusions. Please note that, since the agency revised its 
environmental regulations, there have been no submissions that 
requested an action that would have been subject to the categorical 
exclusion in Sec. 25.32(o). To avoid counting this burden as zero, we 
have estimated the burden for this categorical exclusion at one 
respondent making one submission a year for a total of one annual 
submission. The hours per response values were estimated as follows: 
First, we assumed that the new information requested in this guidance 
for each of these three categorical exclusions is readily available to 
the submitter. For the new information requested for the exclusion in 
Sec. 25.32(i), we expect that submitter will need to gather information 
from appropriate persons in the submitter's company and to prepare this 
information for attachment to the claim for categorical exclusion. We 
believe that this effort should take no longer than 1 hour per 
submission. For the new information requested for the exclusions in 
Sec. 25.32(o) and (q), the submitters will almost always merely need to 
copy existing documentation and attach it to the claim for categorical 
exclusion. We believe that collecting this information should also take 
no longer than 1 hour per submission.

    Dated: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5193 Filed 3-8-04; 8:45 am]