[Federal Register Volume 72, Number 119 (Thursday, June 21, 2007)]
[Notices]
[Pages 34255-34256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11969]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0091]


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 July 
23, 2007.

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: 202-395-6974. 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: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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, 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, 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 CFSAN. The guidance document entitled ``Preparing a Claim of

[[Page 34256]]

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.
    In the Federal Register of March 28, 2007 (72 FR 14581), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                No. of       Annual Frequency     Total Annual       Hours per     Total Burden
      21 CFR Section          Respondents      per Response        Responses         Response          Hours
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25.32(i)                                52                  3                156               1             156
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25.32(o)                                 1                  1                  1               1               1
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25.32(q)                                 7                  2                 14               1              14
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Total                       ..............  .................                171  ..............            171
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimates in table 1 of this document 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 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: June 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11969 Filed 6-20-07; 8:45 am]
BILLING CODE 4160-01-S