Document ID: FDA-2013-N-1147-0007
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2019-11-22T05:00Z

[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Notices]
[Pages 64528-64529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25370]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1147]

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 or we) 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 
December 23, 2019.

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 oira_submission@omb.eop.gov. 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 our 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; 
approving food additive petitions, color additive petitions, generally 
recognized as safe affirmation petitions, and requests for exemption 
from regulation as a food additive; and approving actions on certain 
food labeling citizen petitions, nutrient content claims petitions, and 
health claims petitions. We have provided guidance that contains sample 
formats to help industry submit a claim of categorical exclusion (CE) 
or an environmental assessment (EA) to the Center for Food Safety and 
Applied Nutrition (CFSAN). The 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 CE 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.
    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 June 25, 2019 (84 FR 29864), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

[[Page 64529]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
  21 CFR section/environmental       Number of     responses per   Total annual   Average burden    Total hours
      impact considerations         respondents     respondent       responses     per response
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25.15(a) and (d) (to cover CEs                47               1              47               8             376
 under 25.32(i))................
25.15(a) and (d) (to cover CEs                 1               1               1               8               8
 under 25.32(o))................
25.15(a) and (d) (to cover CEs                 3               1               3               8              24
 under 25.32 (q))...............
25.40(a) and (c) EAs............              57               1              57             180          10,260
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    Total.......................  ..............  ..............  ..............  ..............          10,668
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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 
CEs listed under Sec.  25.32(i) and (q) (21 CFR 25.32(i) and (q)) that 
we have received in the past 3 years. To avoid counting the burden 
attributed to Sec.  25.32(o) 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 burden for submitting a 
categorical exclusion is captured under 21 CFR 25.15(a) and (d).
    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 8 hours per 
submission. For the information requested for the categorical 
exclusions in Sec.  25.32(o) and (q), the submitters will copy existing 
documentation and attach it to the claim for categorical exclusion. We 
believe that collecting this information should take no longer than 8 
hours per submission.
    For the information requested for the environmental assessments in 
21 CFR 25.40(a) and (c), we believe that submitters will submit an 
average of 57 environmental assessments annually. We estimate that each 
submitter will prepare an EA within 3 weeks (120 hours) and revise the 
EA based on Agency comments (between 40 to 60 hours), for a total 
preparation time of 180 hours.
    Based on a current review of the information collection, we have 
made no adjustments to the currently approved estimate.

    Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25370 Filed 11-21-19; 8:45 am]
 BILLING CODE 4164-01-P