[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Pages 64218-64220]
From the Federal Register Online via the Government Publishing 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, [email protected].
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]
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