[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Notices]
[Pages 29864-29866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13434]


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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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 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 August 26, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 26, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-1147 for ``Preparing a Claim of Categorical Exclusion or an 
Environmental Assessment for Submission to the Center for Food Safety 
and Applied Nutrition.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: 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

[[Page 29865]]

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

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 (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. We have provided guidance that contains sample 
formats to help industry submit a claim of categorical exclusion 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 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.
    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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                                                     Number of
21 CFR part environmental impact     Number of     responses per   Total annual   Average burden    Total hours
         considerations             respondents     respondent       responses     per response
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25.15(a) & (d) (to cover CE's                 47               1              47               8             376
 under 25.32(i))................
25.15(a) & (d) (to cover CE's                  1               1               1               8               8
 under 25.32(o))................
25.15(a) & (d) (to cover CE's                  3               1               3               8              24
 under 25.32(q))................
25.40(a) & (c) EA's.............              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 (CE) listed under Sec.  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 Sec.  25.15(a) and (c).
    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 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

[[Page 29866]]

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: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13434 Filed 6-24-19; 8:45 am]
BILLING CODE 4164-01-P


