81 FR 83245 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 224 (November 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 224 (November 21, 2016)
| Page Range | 83245-83246 | |
| FR Document | 2016-27943 |
[Federal Register Volume 81, Number 224 (Monday, November 21, 2016)] [Notices] [Pages 83245-83246] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-27943] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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\ ---------------------------------------------------------------------------------------------------------------- Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response ---------------------------------------------------------------------------------------------------------------- 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 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 10,668 ---------------------------------------------------------------------------------------------------------------- \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
![Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Notices 83245
Submit written requests for single DEPARTMENT OF HEALTH AND color additive petitions, GRAS
copies of the report to the Policy and HUMAN SERVICES affirmation petitions, requests for
Regulations Staff (HFV–6), Center for exemption from regulation as a food
Veterinary Medicine, Food and Drug Food and Drug Administration additive, and actions on certain food
Administration, 7519 Standish Pl., [Docket No. FDA–2013–N–1147] labeling citizen petitions, nutrient
Rockville, MD 20855. Send one self- content claims petitions, and health
addressed adhesive label to assist that Agency Information Collection claims petitions. In 1997, we amended
office in processing your requests. See Activities; Submission for Office of our regulations in part 25 (21 CFR part
the SUPPLEMENTARY INFORMATION section Management and Budget Review; 25) to provide for categorical exclusions
for electronic access to the document. Comment Request; Preparing a Claim for additional classes of actions that do
of Categorical Exclusion or an not individually or cumulatively have a
FOR FURTHER INFORMATION CONTACT: significant effect on the human
Environmental Assessment for
Linda M. Wilmot, Center for Veterinary Submission to the Center for Food environment (62 FR 40570, July 29,
Medicine (HFV–120), Food and Drug Safety and Applied Nutrition 1997). As a result of that rulemaking, we
Administration, 7500 Standish Pl., no longer routinely require submission
Rockville, MD 20855, 240–402–0829, AGENCY: Food and Drug Administration, of information about the manufacturing
linda.wilmot@fda.hhs.gov. HHS. and production of our regulated articles.
ACTION: Notice. We also have eliminated the previously
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 9, 2014 SUMMARY: The Food and Drug required Environmental Assessment
(79 FR 53431), CVM announced that it Administration (FDA) is announcing (EA) and abbreviated EA formats from
was beginning to explore possible that a proposed collection of the amended regulations. Instead, we
changes to the current review processes information has been submitted to the have provided guidance that contains
for NADAs for the use of multiple new Office of Management and Budget sample formats to help industry submit
animal drugs in combination drug (OMB) for review and clearance under a claim of categorical exclusion or an
medicated feeds. In the same Federal the Paperwork Reduction Act of 1995. EA to the Center for Food Safety and
Applied Nutrition (CFSAN). The
Register notice, FDA announced the DATES: Fax written comments on the
guidance document entitled ‘‘Preparing
opening of a docket to receive input collection of information by December
a Claim of Categorical Exclusion or an
from the public on this issue. This effort 21, 2016.
Environmental Assessment for
is consistent with the stated ADDRESSES: To ensure that comments on Submission to the Center for Food
performance goal in the Animal Drug the information collection are received, Safety and Applied Nutrition’’
User Fee Amendments of 2013 (ADUFA OMB recommends that written identifies, interprets, and clarifies
III) goals letter. comments be faxed to the Office of existing requirements imposed by
In the Federal Register of April 29, Information and Regulatory Affairs, statute and regulation, consistent with
2016 (81 FR 25677), FDA published a OMB, Attn: FDA Desk Officer, FAX: the Council on Environmental Quality
notice of availability of a draft CVM 202–395–7285, or emailed to oira_ regulations (40 CFR 1507.3). It consists
report, giving interested persons until submission@omb.eop.gov. All of recommendations that do not
July 29, 2016, to comment. Those comments should be identified with the themselves create requirements; rather,
OMB control number 0910–0541. Also they are explanatory guidance for our
comments were considered as the CVM
include the FDA docket number found own procedures in order to ensure full
working group report was finalized
in brackets in the heading of this compliance with the purposes and
without substantive changes. This document.
report was developed for the provisions of NEPA.
discussions with the regulated industry FOR FURTHER INFORMATION CONTACT: FDA The guidance provides information to
for reauthorization of ADUFA. PRA Staff, Office of Operations, Food assist in the preparation of claims of
and Drug Administration, Three White categorical exclusion and EAs for
Persons with access to the Internet Flint North, 10A63, 11601 Landsdown
may obtain this document on the CVM submission to CFSAN. The following
St., North Bethesda, MD 20852, questions are covered in this guidance:
ADUFA Meetings Web page: http:// PRAStaff@fda.hhs.gov.
www.fda.gov/ForIndustry/UserFees/ (1) What types of industry-initiated
SUPPLEMENTARY INFORMATION: In actions are subject to a claim of
AnimalDrugUserFeeActADUFA/ compliance with 44 U.S.C. 3507, FDA
ucm042891.htm. categorical exclusion? (2) What must a
has submitted the following proposed claim of categorical exclusion include
Dated: November 15, 2016. collection of information to OMB for by regulation? (3) What is an EA? (4)
Leslie Kux, review and clearance. When is an EA required by regulation
Associate Commissioner for Policy. Preparing a Claim of Categorical and what format should be used? (5)
[FR Doc. 2016–27942 Filed 11–18–16; 8:45 am] Exclusion or an Environmental What are extraordinary circumstances?
BILLING CODE 4164–01–P
Assessment for Submission to the and (6) What suggestions does CFSAN
Center for Food Safety and Applied have for preparing an EA? Although
Nutrition—OMB Control Number CFSAN encourages industry to use the
0910–0541—Extension EA formats described in the guidance
asabaliauskas on DSK3SPTVN1PROD with NOTICES
As an integral part of its decision because standardized documentation
making process, we are obligated under submitted by industry increases the
the National Environmental Policy Act efficiency of the review process,
of 1969 (NEPA) to consider the alternative approaches may be used if
environmental impact of our actions, these approaches satisfy the
including allowing notifications for food requirements of the applicable statutes
contact substances to become effective and regulations. We are requesting the
and approving food additive petitions, extension of OMB approval for the
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![83246 Federal Register / Vol. 81, No. 224 / Monday, November 21, 2016 / Notices
information collection provisions in the used in materials that come into contact information. No comments were
guidance. with food. received.
Description of Respondents: The In the Federal Register of August 25,
We estimate the burden of this
likely respondents include businesses 2016 (81 FR 58517), FDA published a
collection of information as follows:
engaged in the manufacture or sale of 60-day notice requesting public
food, food ingredients, and substances comment on the proposed collection of
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
25.15 (a) & (d) (to cover CEs under 25.32(i)) ..................... 47 1 47 8 376
25.15 (a) &(d) (to cover CEs under 25.32(o)) ..................... 1 1 1 8 8
25.15 (a) &(d) (to cover CEs under 25.32(q)) ..................... 3 1 3 8 24
25.40 (a) & (c) EAs .............................................................. 57 1 57 180 10,260
Total .............................................................................. ........................ ........................ ........................ ........................ 10,668
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimates for respondents and the EA based on Agency comments department-wide system of records,
numbers of responses are based on the (between 40 to 60 hours), for a total System No. 09–90–1601 ‘‘Outside
annualized numbers of petitions and preparation time of 180 hours. The Experts Recruited for Non-FACA
notifications qualifying for categorical burden relating to this collection has Activities,’’ and deleting four related
exclusions listed under § 25.32(i) and been previously approved under OMB systems of records that are obsolete or
(q) that the Agency has received in the control number 0910–0322, that will be rendered duplicative by the
past 3 years. Please note that, in the past ‘‘Environmental Impact Consideration— new system. The new system will cover
3 years, there have been no submissions 21 CFR part 25’’. Upon approval of this recruitment and other administrative
that requested an action that would collection of information by OMB, FDA records about individuals outside the
have been subject to the categorical will revise OMB control number 0910– HHS workforce who serve or are
exclusion in § 25.32(o). To avoid 0322 to remove the annual reporting considered for service on HHS mission-
counting this burden as zero, we have burden for categorical exclusions and related committees and other
estimated the burden for this categorical environmental assessment requests assignments requiring specific outside
exclusion at one respondent making one related to food additive petitions, color expertise or experience (excluding those
submission a year for a total of one additive petitions, requests for that are subject to the Federal Advisory
annual submission. The burden for exemption from regulation as a food Committee Act (FACA), which are
submitting a categorical exclusion is additive, and submission of a food covered under System No. 09–90–0059).
captured under § 25.15(a) and (d). contact notification for a food contact The new department-wide System No.
To calculate the estimate for the hours substance. The future burden for 09–90–1601 and the related system
per response values, we assumed that categorical exclusion or environmental deletions are more fully explained in
the information requested in this assessments for these requests will be the SUPPLEMENTARY INFORMATION section
guidance for each of these three captured under OMB control number of this Notice.
categorical exclusions is readily 0910–0541, this collection of DATES: The new system of records
available to the submitter. For the information. established in this Notice is effective
information requested for the exclusion upon publication, with the exception of
in § 25.32(i), we expect that submitter Dated: November 15, 2016.
Leslie Kux, the routine uses. The routine uses will
will need to gather information from be effective 30 days after publication of
appropriate persons in the submitter’s Associate Commissioner for Policy.
this Notice, unless comments are
company and prepare this information [FR Doc. 2016–27943 Filed 11–18–16; 8:45 am]
received that warrant a revision to this
for attachment to the claim for BILLING CODE 4164–01–P
Notice. Written comments on the Notice
categorical exclusion. We believe that should be submitted within 30 days.
this effort should take no longer than 8 The deletion of System Numbers 09–20–
hours per submission. For the DEPARTMENT OF HEALTH AND
HUMAN SERVICES 0168, 09–30–0049, 09–37–0022, and 09–
information requested for the categorical 90–0080 will be effective 30 days after
exclusions in § 25.32(o) and (q), the publication of this Notice.
submitters will almost always merely Office of the Secretary
ADDRESSES: The public should address
need to copy existing documentation Privacy Act of 1974; System of
and attach it to the claim for categorical written comments to: Beth Kramer, HHS
Records Notice Privacy Act Officer, FOIA/PA Division,
exclusion. We believe that collecting
this information should also take no Hubert H. Humphrey Building—Suite
asabaliauskas on DSK3SPTVN1PROD with NOTICES
AGENCY: Department of Health and
longer than 8 hours per submission. Human Services (HHS), Office of the 729H, 200 Independence Avenue SW.,
For the information requested for the Secretary (OS) Washington, DC 20201, beth.kramer@
environmental assessments in § 25.40(a) hhs.gov.
ACTION: Notice to establish a new system
and (c), we believe that submitters will of records, and to delete related systems. FOR FURTHER INFORMATION CONTACT: Beth
submit an average of 57 environmental Kramer, HHS Privacy Act Officer, FOIA/
assessments annually. We estimate that SUMMARY: In accordance with the PA Division, Hubert H. Humphrey
each submitter will prepare an EA requirements of the Privacy Act of 1974, Building—Suite 729H, 200
within 3 weeks (120 hours) and revise as amended, HHS is establishing a new, Independence Avenue SW.,
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Document Created: 2018-02-14 08:34:05
Document Modified: 2018-02-14 08:34:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by December 21, 2016. | |
| 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] | |
| FR Citation | 81 FR 83245 |
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