Notice2025-18188
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 19, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 180 (Friday, September 19, 2025)</title>
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[Federal Register Volume 90, Number 180 (Friday, September 19, 2025)]
[Notices]
[Pages 45225-45227]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18188]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0706]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Environmental Impact
Considerations
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: Submit written comments (including recommendations) on the
collection of information by October 20, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0322. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#68383a293b1c090e0e280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="2e7e7c6f7d5a4f48486e484a4f0046465d00494158">[email protected]</span></a>.
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.
Environmental Impact Considerations
OMB Control Number 0910-0322--Extension
FDA is requesting OMB approval for the reporting requirements
contained in the FDA collection of information ``Environmental Impact
Considerations.'' The National Environmental Policy Act of 1969 (NEPA)
(42 U.S.C. 4321-4347) states national environmental objectives and
imposes upon each Federal Agency the duty to consider the environmental
effects of its actions. Section 106(b) of NEPA provides for the
preparation of an environmental impact statement (EIS) for a proposed
Federal Agency action requiring an environmental document that has a
reasonably foreseeable significant effect on the quality of the human
environment. Section 106(b) of NEPA further provides for the
preparation of an environmental assessment (EA) for a proposed Federal
Agency action that does not have a reasonably foreseeable significant
effect on the quality of the human environment, or if the significance
of such effect is unknown, unless the Agency finds that the proposed
Federal Agency action is excluded pursuant to one of the Federal
Agency's categorical exclusions (CE). Certain classes of actions that a
Federal Agency has determined normally do not, individually or
cumulatively, have a significant effect on the quality of the human
environment are ordinarily--or categorically--excluded from the
requirement to prepare an EA or EIS (see, e.g., section 106(a) of
NEPA).
This information collection supports implementation of NEPA,
consistent with FDA's authority under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) and the Public Health Service (PHS) Act.
Certain requests for FDA action require the preparation of a CE, EA, or
EIS. FDA's regulations in part 25 (21 CFR part 25) implement the
portions of NEPA that are relevant to FDA in a manner that is
consistent with FDA's authority under the FD&C Act and the PHS Act.
These regulations (Environmental Impact Considerations) set forth FDA
procedures with regard to NEPA requirements by identifying actions that
require the preparation of an environmental document and discussing the
preparation of such documents. These regulations also supplement the
procedures included in the ``HHS General Administration Manual, part
30: Environmental Protection'' (45 FR 76519, November 19, 1980).
A categorical exclusion applies to certain classes of FDA-regulated
actions that usually have little or no potential to cause significant
environmental effects and are excluded from the requirements to prepare
an EA or EIS. Section 25.15(a) and (d) specifies the procedures for
submitting to FDA a claim for a categorical exclusion. Extraordinary
circumstances (Sec. 25.21), which may result in significant
environmental impacts, may exist for some actions that are usually
categorically excluded that may result in the need for an EA. An EA
provides information that is used to determine whether an FDA action
could result in a significant environmental impact. Section 25.40(a)
and (c) specify the content requirements for EAs for non-excluded
actions. Where the Agency finds that no significant environmental
effects is expected, a finding of no significant impact is prepared.
This collection of information is used by FDA to assess the
environmental impact of Agency actions and to ensure that the public is
informed of environmental analyses. Firms wishing to manufacture and
market substances regulated under statutes for which FDA is responsible
must, in most instances, submit applications requesting approval.
Environmental information must be included in such applications for the
purpose of determining whether the proposed action may have a
significant impact on the environment. Where significant adverse events
cannot be avoided, the submitted information is used to prepare and
circulate to the public an EIS, when applicable, made
[[Page 45226]]
available through a Federal Register document also filed for comment at
the Environmental Protection Agency. The final EIS, including the
comments received, is reviewed by the Agency to weigh environmental
costs and benefits in determining whether to pursue the proposed action
or some alternative that would reduce expected environmental impact.
Any final EIS would contain, when applicable, additional
information gathered by the Agency after the publication of the draft
EIS, a copy or a summary of the comments received on the draft EIS, and
the Agency's responses to the comments, including any revisions
resulting from the comments or other information. In cases requiring an
EIS, the Agency prepares a record of decision pursuant to Sec. 25.43.
In the Federal Register of July 2, 2025 (90 FR 29011), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates 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 25; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Sections 25.20, 25.40, and 25.42; Actions Requiring an EA or an EIS:
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Center for Drug Evaluation and 13 1 13 3,400 44,200
Research (CDER)................
Center for Devices and 66 1 66 3,400 224,400
Radiological Health (CDRH).....
Center for Biologics Evaluation 4 1 4 3,400 13,600
and Research (CBER)............
Center for Veterinary Medicine 11 1 11 2,160 23,760
(CVM)..........................
Center for Tobacco Products 14 1 14 80 1,120
(CTP)..........................
Human Foods Program (HFP)....... 60 1 60 180 10,800
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Subtotal.................... 168 .............. 168 .............. 317,880
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Section 25.15(a) and (d); Actions Subject to CE:
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CDER............................ 3,999 5.0765 20,301 8 162,408
CDRH............................ 66 1 66 6 396
CBER............................ 2,383 3 7,149 8 57,192
CVM............................. 116 6.47 751 3 2,253
HFP............................. 50 1 50 8 400
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Subtotal.................... 6,614 .............. 28,317 .............. 222,649
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Total................... 6,782 .............. 28,485 .............. 540,529
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
CDER
Under Sec. Sec. 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and
314.94(a)(9)(i)), each investigational new drug application (IND), new
drug application (NDA), and abbreviated new drug application (ANDA)
must contain a claim for CE under Sec. 25.30 or Sec. 25.31, or an EA
under Sec. 25.40.
CDRH
Under Sec. 814.20(b)(11) (21 CFR 814.20(b)(11)), premarket
approval applications (PMAs) (original PMAs and supplements) must
contain a claim for CE under Sec. 25.30 or Sec. 25.34 or an EA under
Sec. 25.40.
CBER
Under 21 CFR 601.2(a), biologic license applications (BLAs) as well
as INDs (Sec. 312.23), NDAs (Sec. 314.50), ANDAs (Sec. 314.94), and
PMAs (Sec. 814.20) must contain either a claim of CE under Sec. 25.30
or Sec. 25.31 or an EA under Sec. 25.40.
CVM
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1)
supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new
animal drug applications and generic investigational new animal drug
applications, and 21 CFR 571.1(c) food additive petitions (FAPs), 21
CFR 516.129(c)(9) requests for determination of eligibility for
indexing, and 21 CFR 510.205(e)(7) establishment of an import tolerance
must contain a claim for CE under Sec. 25.30, Sec. 25.32, or Sec.
25.33, or an EA under Sec. 25.40.
CTP
Under sections 905, 910, and 911 of the FD&C Act (21 U.S.C. 387e,
387j, and 387k), product applications and supplements, premarket
tobacco applications (PMTAs), substantial equivalences (SEs), exemption
from SEs, and modified risk tobacco product applications must contain a
claim for a CE or an EA. Upon evaluation, we have concluded that the
majority of the EA burden for tobacco products is accounted for in
other information collections currently approved by OMB. The burden we
attribute to SEs is currently approved in OMB control number 0910-0673;
the burden we attribute to PMTAs is currently approved in OMB control
number 0910-0768; and the burden we attribute to SE exemptions is
currently approved in OMB control number 0910-0684.
HFP
Under Sec. 25.20, the following actions normally require at least
the preparation of an EA, unless the action qualifies for categorical
exclusion: establishment by regulation of labeling requirements, a
standard, or a monograph, unless categorically excluded in Sec.
25.30(k) or Sec. 25.31(a), (b), (c), (h), (i), or (j), or Sec.
25.32(a) or (p); withdrawal of existing approvals of FDA-approved
articles, unless categorically excluded in Sec. 25.31(d) or (k), Sec.
25.32(m), or Sec. 25.33(g) or (h); approval of food additive petitions
and color additive petitions, approval of requests for
[[Page 45227]]
exemptions for investigational use of food additives, the granting of
requests for exemption from regulation as a food additive under 21 CFR
170.39 of this chapter, and allowing notifications submitted under 21
U.S.C. 348(h) to become effective, unless categorically excluded in
Sec. 25.32(b), (c), (i), (j), (k), (l), (o), (q), or (r).
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) that the Agency has 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 claim of CE at
one respondent making one submission a year for a total of one annual
submission. The burden for submitting a claim of CE is captured under
Sec. 25.15(a) and (d).
Based on a review of the information collection since our last
request for OMB approval, we have made adjustments to our burden
estimate. Our estimated burden for the information collection reflects
an overall increase of 215,125 hours and a decrease of 1,938 responses.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18188 Filed 9-18-25; 8:45 am]
BILLING CODE 4164-01-P
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