[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual Hours per
Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
25.32(i) 34 1 34 1 34
----------------------------------------------------------------------------------------------------------------
25.32(o) 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
25.32(q) 2 1 2 1 2
----------------------------------------------------------------------------------------------------------------
Total 37
----------------------------------------------------------------------------------------------------------------
\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
[[Page 42448]]
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