[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59722-59723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0373]


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.

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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 October 
28, 2010.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0541. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 
Nutrition (OMB Control Number 0910-0541)--Extension

    As an integral part of its decisionmaking process, FDA is obligated 
under the National Environmental Policy Act of 1969 (NEPA) to consider 
the environmental impact of its actions, including allowing 
notifications for food contact substances to become effective and 
approving food additive petitions, color additive petitions and GRAS 
petition requests for exemption from regulation as a food additive, and 
actions on certain food labeling citizen petitions, nutrient content 
claims petitions, and health claims petitions. In 1997, FDA amended its 
regulations in part 25 (21 CFR part 25) to provide for categorical 
exclusions for additional classes of actions that do not individually 
or cumulatively have a significant effect on the human environment (62 
FR 40570, July 29, 1997). As a result of that rulemaking, FDA no longer 
routinely requires submission of information about the manufacturing 
and production of FDA-regulated articles. FDA also has eliminated the 
previously required Environmental Assessment (EA) and abbreviated EA 
formats from the amended regulations. Instead, FDA has provided 
guidance that contains sample formats to help industry submit a claim 
of categorical exclusion or an EA to FDA's Center for Food Safety and 
Applied Nutrition (CFSAN). The guidance document entitled ``Preparing a 
Claim of Categorical Exclusion or an Environmental Assessment for 
Submission to the Center for Food Safety and Applied Nutrition'' 
identifies, interprets, and clarifies existing requirements imposed by 
statute and regulation, consistent with the Council on Environmental 
Quality regulations (40 CFR 1507.3). It consists of recommendations 
that do not themselves create requirements; rather, they are 
explanatory guidance for FDA's own procedures in order to ensure full 
compliance with the purposes and provisions of NEPA.
    The guidance provides information to assist in the preparation of 
claims of categorical exclusion and EAs for submission to CFSAN. The 
following

[[Page 59723]]

questions are covered in this guidance: (1) What types of industry-
initiated actions are subject to a claim of categorical exclusion? (2) 
what must a claim of categorical exclusion include by regulation? (3) 
what is an EA? (4) when is an EA required by regulation and what format 
should be used? (5) what are extraordinary circumstances? and (6) what 
suggestions does CFSAN have for preparing an EA? Although CFSAN 
encourages industry to use the EA formats described in the guidance 
because standardized documentation submitted by industry increases the 
efficiency of the review process, alternative approaches may be used if 
these approaches satisfy the requirements of the applicable statutes 
and regulations. FDA is requesting the extension of OMB approval for 
the information collection provisions in the guidance. 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.
    In the Federal Register of July 21, 2010 (75 FR 42446), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. In response, the agency received one comment 
that was not responsive to the comment request on the information 
collection provisions.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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  21 CFR          No. of          Annual Frequency       Total Annual          Hours per
  Section       Respondents         per Response           Responses           Response           Total Hours
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25.32(i)                    34                     1                  34                   1                  34
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25.32(o)                     1                     1                   1                   1                   1
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25.32(q)                     2                     1                   2                   1                   2
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Total                                                                                                         37
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The 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 in the past 3 
years. Please note that, in the past 3 years, 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, FDA has estimated the burden for this categorical 
exclusion at one respondent making one submission a year for a total of 
one annual submission.
    To calculate the estimate for the hours per response values, we 
assumed that the information requested in this guidance for each of 
these three categorical exclusions is readily available to the 
submitter. For the information requested for the exclusion in Sec.  
25.32(i), we expect that the 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 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: September 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24272 Filed 9-27-10; 8:45 am]
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