
[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Pages 64218-64220]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1147]


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 or we) 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 of our guidance

[[Page 64219]]

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 December 27, 2013.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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

    As an integral part of its decision making process, we are 
obligated under the National Environmental Policy Act of 1969 (NEPA) to 
consider the environmental impact of our actions, including allowing 
notifications for food contact substances to become effective and 
approving food additive petitions, color additive petitions, Generally 
Recognized As Safe 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, we amended our 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, we no longer routinely require submission of 
information about the manufacturing and production of our regulated 
articles. We also have eliminated the previously required Environmental 
Assessment (EA) and abbreviated EA formats from the amended 
regulations. Instead, we have provided guidance that contains sample 
formats to help industry submit a claim of categorical exclusion or an 
EA to 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 our 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. We are 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.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      No. of                          Average
  21 CFR Part 25; Environmental       No. of       responses per   Total annual     burden per      Total hours
      impact considerations         respondents     respondent       responses       response
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Sec.   25.32(i).................              42               1              42               1              42
Sec.   25.32(o).................               1               1               1               1               1
Sec.   25.32(q).................               2               1               2               1               2
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    Total.......................  ..............  ..............  ..............  ..............              45
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 64220]]

    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 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, we have 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 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: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25300 Filed 10-25-13; 8:45 am]
BILLING CODE 4160-01-P


