[Federal Register Volume 90, Number 125 (Wednesday, July 2, 2025)]
[Notices]
[Pages 29011-29014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-12307]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0706]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Environmental Impact Considerations
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 information collection associated with
Environmental Impact Considerations.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 2, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 2, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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-N-2025-0706 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Environmental Impact
Considerations.'' 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, 240-402-7500.
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
[[Page 29012]]
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.govinfo.gov/content/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, 240-402-7500.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
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 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.
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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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
21 CFR part 25; activity Number of responses per annual burden per Total hours
respondents respondent responses 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 Research 13 1 13 3,400 44,200
(CDER).....................................
Center for Devices and Radiological Health 66 1 66 3,400 224,400
(CDRH).....................................
Center for Biologics Evaluation and Research 4 1 4 3,400 13,600
(CBER).....................................
Center for Veterinary Medicine (CVM)........ 11 1 11 2,160 23,760
Center for Tobacco Products (CTP)........... 14 1 14 80 1,120
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
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 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
[[Page 29014]]
215,125 hours and a decrease of 1,938 responses.
Dated: June 25, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12307 Filed 7-1-25; 8:45 am]
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