Notice2022-17154
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
Primary source
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Published
August 10, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 153 (Wednesday, August 10, 2022)</title>
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[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48677-48678]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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#a1f1f3e0f2d5c0c7c7e1c7c5c08fc9c9d28fc6ced7"><span class="__cf_email__" data-cfemail="ffafadbeac8b9e9999bf999b9ed197978cd1989089">[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--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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparing-claim-categorical-exclusion-or-environmental-assessment-submission-cfsan">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparing-claim-categorical-exclusion-or-environmental-assessment-submission-cfsan</a>, 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\
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Number of
21 CFR part 25; activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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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).
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Subtotal................................. .............. .............. 97 ......................................... 88,620
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Section 25.15(d); actions subject to CE:
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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
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CFSAN........................................ 51 1 51 8........................................ 408
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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
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