[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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