Document ID: FDA-2012-N-0961-0016
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review;
 Comment Request; Environmental Impact Considerations
Posted Date: 2022-08-10T04:00Z

[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48677-48678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17154]

[[Page 48677]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0961]

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, Agency, or we) 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 September 9, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. 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, 
[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.

Environmental Impact Considerations

OMB Control Number 0910-0322--Revision

    This information collection helps support implementation of the 
National Environmental Policy Act (NEPA), consistent with FDA's 
authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 
the Public Health Service Act. All applications or petitions requesting 
FDA action require the submission of an environmental assessment (EA) 
or a claim of categorical exclusion (CE). A CE applies to Agency 
actions that usually have little or no potential to cause significant 
environmental effects and are excluded from the requirements to prepare 
an EA or environmental impact statement (EIS). Regulations in part 25 
(21 CFR part 25) set forth FDA procedures with regard to NEPA 
requirements (part 25, subpart A); identify actions that require the 
preparation of an EA (part 25, subpart B); explain CEs (part 25, 
subpart C); and discuss the preparation of documents (part 25, subpart 
D). The regulations also supplement procedural provisions of NEPA that 
were published by the Council on Environmental Quality (CEQ) in 40 CFR 
parts 1500 through 1508 and the procedures included in the ``HHS 
General Administration Manual, part 30: Environmental Protection'' (45 
FR 76519 to 76534, November 19, 1980).
    In the Federal Register of August 25, 2021 (86 FR 47501), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited. 
On our own initiative and for efficiency of Agency operations, we are 
revising the information collection to account for burden that may 
result from recommendations found in Agency guidance and currently 
approved in OMB control number 0910-0541. 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 applicable statutes and regulations, consistent 
with the CEQ regulations (40 CFR 1507.3). It consists of 
recommendations that do not themselves create requirements; rather, 
they are explanatory guidance for FDA's own procedures in order to 
ensure full compliance with the purposes and provisions of NEPA. The 
guidance document is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparing-claim-categorical-exclusion-or-environmental-assessment-submission-cfsan, and was issued consistent with our Good Guidance Practice 
regulations in 21 CFR 10.115, which provide for public comment at any 
time.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
           21 CFR part 25; activity               Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Section 25.40(c); actions excluded from the requirement to prepare EA or EIS:
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Center for Drug Evaluation and Research                    14          0.9285              13  3,400....................................          44,200
 (CDER).
Center for Devices and Radiological Health                  0  ..............               0  .........................................               0
 (CDRH).
Center for Biologics Evaluation and Research                4               1               4  3,400....................................          13,600
 (CBER).
Center for Veterinary Medicine (CVM).........               9               1               9  2,160....................................          19,440
Center for Tobacco Products (CTP)............              14               1              14  80.......................................           1,120
Center for Food Safety and Applied Nutrition               57               1              57  180......................................          10,260
 (CFSAN).
                                              ----------------------------------------------------------------------------------------------------------
    Subtotal.................................  ..............  ..............              97  .........................................          88,620
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                                                        Section 25.15(d); actions subject to CE:
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER.........................................           5,186          4.2273          21,923  8........................................         175,384
CDRH.........................................              62               1              62  6........................................             372
CBER.........................................           3,575               2           7,150  8........................................          57,200
CVM..........................................             114              10           1,140  2,160....................................           3,420
CTP..........................................               0  ..............               0  .........................................               0

[[Page 48678]]

 
CFSAN........................................              51               1              51  8........................................             408
                                              ----------------------------------------------------------------------------------------------------------
    Subtotal.................................  ..............  ..............          30,326  .........................................         236,784
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        Total................................  ..............  ..............          30,423  .........................................         325,404
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\1\ There are no capital, or operational and maintenance costs associated with the information collection.

    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 
approvals (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.  25.32 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 must contain 
a claim for CE under Sec.  25.30 or Sec.  25.32 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.
    CFSAN:
    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).
    As a result of revising the information collection to include 
submissions made to CFSAN, it reflects an increase in burden of 108 
responses and 10,668 hours annually.

    Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17154 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P