[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)]
[Notices]
[Pages 83245-83246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27943]


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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) 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 21, 2016.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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 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, 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, 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 the 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 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

[[Page 83246]]

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 August 25, 2016 (81 FR 58517), FDA 
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:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15 (a) & (d) (to cover CEs                 47               1              47               8             376
 under 25.32(i))................
25.15 (a) &(d) (to cover CEs                   1               1               1               8               8
 under 25.32(o))................
25.15 (a) &(d) (to cover CEs                   3               1               3               8              24
 under 25.32(q))................
25.40 (a) & (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 
categorical exclusions listed under 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. The burden for submitting a 
categorical exclusion is captured under Sec.  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 submitter will need to gather information from 
appropriate persons in the submitter's company and 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 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 8 hours per submission.
    For the information requested for the environmental assessments in 
Sec.  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. The burden relating to this collection 
has been previously approved under OMB control number 0910-0322, 
``Environmental Impact Consideration--21 CFR part 25''. Upon approval 
of this collection of information by OMB, FDA will revise OMB control 
number 0910-0322 to remove the annual reporting burden for categorical 
exclusions and environmental assessment requests related to food 
additive petitions, color additive petitions, requests for exemption 
from regulation as a food additive, and submission of a food contact 
notification for a food contact substance. The future burden for 
categorical exclusion or environmental assessments for these requests 
will be captured under OMB control number 0910-0541, this collection of 
information.

    Dated: November 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27943 Filed 11-18-16; 8:45 am]
 BILLING CODE 4164-01-P