[Federal Register: March 9, 2004 (Volume 69, Number 46)]
[Notices]
[Page 11018-11019]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr04-85]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0379]
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.
-----------------------------------------------------------------------
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 April
8, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
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
FDA's regulation in 21 CFR 25.20 specifies the types of actions
related to food additive petitions, color additive petitions, requests
for exemption from regulation as a food additive under Sec. 170.39 (21
CFR 170.39), notifications for food contact substances under section
409(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
348(h)), generally recognized as safe (GRAS) affirmation petitions, and
citizen petitions for certain food labeling regulations that require at
least
[[Page 11019]]
the preparation of an environmental assessment (EA), unless the action
qualifies for a categorical exclusion under 21 CFR 25.30 or 25.32.
FDA's regulations in part 25 (21 CFR part 25) are based upon the
requirements of the National Environmental Policy Act (NEPA) (42 U.S.C.
4321 et seq.). The agency's collection of information on food additives
and food-contact substances is based upon the requirements in section
409 of the act. Likewise, section 721 of the act (21 U.S.C. 379(e))
provides for the collection of information on color additives. The
submission to FDA by interested parties of a GRAS affirmation petition
is voluntary. The information to be submitted with a GRAS affirmation
petition is listed in Sec. 170.35 (21 CFR 170.35), including, in Sec.
170.35(c)(1)(viii), the environmental information to be submitted. The
environmental information to be submitted with petitions for certain
food labeling regulations is listed in 21 CFR 101.12(h)(12) and
101.69(h) and in paragraph F of the form for petitions for a health
claim in 21 CFR 101.70(f).
Thus, FDA collects information on the potential for environmental
impacts of its actions in the form of environmental assessments and
claims for categorical exclusions from interested parties who request
agency action by submitting to the agency any of the above listed
petitions, requests for exemption, or food contact substance
notifications. After this information has been collected, the agency
will use it to determine whether its action may significantly affect
the quality of the human environment.
FDA has collected information from interested parties requesting
agency action for many years. Over the years, this collected
information has taken several different forms. The agency amended its
environmental regulations in the 1997 rule to reduce the number of NEPA
evaluations by providing for categorical exclusions for additional
classes of actions that do not individually or cumulatively have a
significant affect on the quality of the human environment. In the 1997
rule, FDA also removed the formats for EAs from its regulations and,
instead, now directs interested parties to the agency's centers for
information on what is needed in EAs. This draft guidance is FDA's
current thinking on what information is needed for the environmental
documentation of the actions that are most often requested. The draft
guidance contains requests for certain information that has not been
requested routinely in the past. FDA is now requesting that submitters
provide certain information to support their claims that the
categorical exclusions listed in Sec. 25.32(i), (o), and (q) will be
applicable to their requested actions. Since these informational
requests are new, FDA is requesting approval from OMB for this
collection of information. The remainder of the environmental
information requests are covered by the information collection
approvals for the underlying actions, i.e., the OMB control number for
food additive petitions is 0910-0016; for color additive petitions,
0910-0185; for requests for exemption from regulation as a food
additive under Sec. 170.39, 0910-0298; for notifications for food
contact substances, 0910-0480; for GRAS affirmation petitions, 0910-
0132; and for petitions for food labeling regulations, 0910-0183.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency
21 CFR Section No. of Respondents per Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.32(i) 68 2 136 1 136
25.32(o) 1 1 1 1 1
25.32(q) 5 2 10 1 10
Total .......................... .................. ....................... .................. 147
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
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 since
its environmental regulations were amended to include additional
categorical exclusions. Please note that, since the agency revised its
environmental regulations, 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. The hours per response values were estimated as follows:
First, we assumed that the new information requested in this guidance
for each of these three categorical exclusions is readily available to
the submitter. For the new 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 new 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: March 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5193 Filed 3-8-04; 8:45 am]
BILLING CODE 4160-01-S