81 FR 58517 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 165 (August 25, 2016)

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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.''

[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Notices]
[Pages 58517-58519]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20369]


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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 we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 October 24, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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

[[Page 58518]]

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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``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.'' Received comments will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://www.regulations.gov or at 
the Division of Dockets Management 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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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: 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 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, 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

[[Page 58519]]

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 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.
    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 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 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 (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 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 from 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: August 19, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20369 Filed 8-24-16; 8:45 am]
 BILLING CODE 4164-01-P