[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Notices]
[Pages 78973-78974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30998]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 January 
27, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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, 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, 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, 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 the 
industry submit a claim of categorical exclusion or an EA to the 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 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? CFSAN encourages the industry to use the EA formats described in 
the guidance because standardized documentation submitted by industry 
increases the

[[Page 78974]]

efficiency of the review process. Although 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.
    In the Federal Register of October 28, 2013 (78 FR 64218), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received. However, the 
comment was beyond the scope of the collection of information's four 
topics that are being solicited. Therefore, it will not be discussed in 
this document.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
  21 CFR Part 25; Environmental      Number of     responses per   Total annual   Average burden    Total hours
      impact considerations         respondents     respondent       responses     per 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.

    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 for each of these three 
categorical exclusions in this guidance 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 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: December 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30998 Filed 12-26-13; 8:45 am]
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