[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Notices]
[Pages 42446-42448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions in 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.''

DATES:  Submit either electronic or written comments on the collection 
of information by September 20, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c)

[[Page 42447]]

and includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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, GRAS 
affirmation petitions, 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 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.
    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 
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

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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: July 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17751 Filed 7-20-10; 8:45 am]
BILLING CODE 4160-01-S