Agency information collection activities; proposals, submissions, and approvals , 34255-34256 [E7-11969]
Agencies
[Federal Register: June 21, 2007 (Volume 72, Number 119)]
[Notices]
[Page 34255-34256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn07-45]
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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]
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