Notice2022-02475
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
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Published
February 7, 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 25 (Monday, February 7, 2022)</title>
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[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6872-6875]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02475]
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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 March 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
[[Page 6873]]
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#4d1d1f0c1e392c2b2b0d2b292c6325253e632a223b"><span class="__cf_email__" data-cfemail="257577647651444343654341440b4d4d560b424a53">[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
I. Background
FDA is requesting OMB approval for the reporting requirements
contained in the FDA collection of information ``Environmental Impact
Considerations.'' The National Environmental Policy Act (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 102(2)(C) of NEPA requires the preparation of
an environmental impact statement (EIS) for every major Federal action
that will significantly affect the quality of the human environment.
FDA's NEPA regulations are in part 25 (21 CFR part 25). All
applications or petitions requesting Agency action require the
submission of a claim for categorical exclusion or an environmental
assessment (EA). 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) (21 CFR
25.15(a) and (d)) specifies the procedures for submitting to FDA a
claim for a categorical exclusion. Extraordinary circumstances (21 CFR
25.21), which may result in significant environmental impacts, may
exist for some actions that are usually categorically excluded. 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) (21 CFR 25.40(a) and (c)) specifies the content requirements
for EAs for non-excluded actions.
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 Agency uses the submitted information as the
basis for preparing and circulating to the public an EIS, 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.
Any final EIS would contain 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. When the Agency finds that no significant
environmental effects are expected, the Agency prepares a finding of no
significant impact.
In the Federal Register of August 25, 2021 (86 FR 47501), FDA
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.
FDA estimates the burden of this collection of information as
follows:
II. Estimated Annual Reporting Burden for Human Drugs (Including
Biologics in the Center for Drug Evaluation and Research)
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 categorical exclusion under Sec. 25.30 (21
CFR 25.30) or Sec. 25.31 (21 CFR 25.31), or an EA under Sec. 25.40.
Annually, FDA receives approximately 5,503 INDs from 3,717 sponsors;
142 NDAs from 111 applicants; 3,285 supplements to NDAs from 516
applicants; 35 biologic license applications (BLAs) from 32 applicants;
777 supplements to BLAs from 89 applicants; 743 ANDAs from 239
applicants; and 11,438 supplements to ANDAs from 482 applicants. FDA
estimates that it receives approximately 21,923 claims for categorical
exclusions as required under Sec. 25.15(a) and (d) and 13 EAs as
required under Sec. 25.40(a) and (c). Based on information provided by
the pharmaceutical industry, FDA estimates that it takes sponsors or
applicants approximately 8 hours to prepare a claim for a categorical
exclusion and approximately 3,400 hours to prepare an EA. Based on
recent numbers, we now estimate a total of 21,936 annual responses and
219,584 hours for human drugs (an increase of 6,489 responses and
62,088 hours).
Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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25.15(a) and (d)................ 5,186 4.2273 21,923 8 175,384
25.40(a) and (c)................ 14 0.9285 13 3,400 44,200
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Total....................... 219,584 .............. .............. .............. ..............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 6874]]
III. Estimated Annual Reporting Burden for Medical Devices
Under Sec. 814.20(b)(11) (21 CFR 814.20(b)(11)), premarket
approvals (PMAs) (original PMAs and supplements) must contain a claim
for categorical exclusion under Sec. 25.30 or 21 CFR 25.34 or an EA
under Sec. 25.40. In 2020, FDA received an average of 62 claims
(original PMAs and supplements) for categorical exclusions as required
under Sec. 25.15(a) and (d), and 0 EAs as required under Sec.
25.40(a) and (c). FDA estimates that approximately 62 respondents will
submit an average of 1 application for categorical exclusion annually.
Based on information provided by sponsors, FDA estimates that it takes
approximately 6 hours to prepare a claim for a categorical exclusion.
Based on recent numbers, we now estimate a total of 62 annual responses
and 372 hours for medical devices (an increase of 12 responses and 72
hours).
Table 2--Estimated Annual Reporting Burden for Medical Devices \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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25.15(a) and (d)................................................... 62 1 62 6 372
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
IV. Estimated Annual Reporting Burden for Biological Products, Drugs,
and Medical Devices in the Center for Biologics Evaluation and Research
Under 21 CFR 601.2(a), 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 categorical exclusion under Sec. 25.30 or
Sec. 25.32 (21 CFR 25.32) or an EA under Sec. 25.40. Annually, FDA
receives approximately 11 BLAs from 11 applicants, 1,080 BLA
supplements to license applications from 160 applicants, 7,017 INDs
from 2,087 sponsors, 1 NDA from 1 applicant, 16 supplements to NDAs
from 6 applicants, 1 ANDA from 1 applicant, 3 supplements to ANDAs from
2 applicants, 1 PMA from 1 applicant, and 79 PMA supplements from 19
applicants. FDA estimates that approximately 10 percent of these
supplements would be submitted with a claim for categorical exclusion
or an EA.
FDA estimates that it has received approximately 7,150 claims for
categorical exclusion as required under Sec. 25.15(a) and (d) annually
and 4 EAs as required under Sec. 25.40(a) and (c) annually. Therefore,
FDA estimates that approximately 3,575 respondents will submit an
average of 2 applications for categorical exclusion and 4 respondents
will submit an average of 1 EA. Based on information provided by
industry, FDA estimates that it takes sponsors and applicants
approximately 8 hours to prepare a claim of categorical exclusion and
approximately 3,400 hours to prepare an EA for a biological product.
Based on recent numbers, we now estimate a total of 7,154 annual
responses and 70,800 hours for human drugs (an increase of 6,658
responses and 60,048 hours).
Table 3--Estimated Annual Reporting Burden for Biological Products \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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25.15(a) and (d)................ 3,575 2 7,150 8 57,200
25.40(a) and (c)................ 4 1 4 3,400 13,600
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Total....................... .............. .............. .............. .............. 70,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
V. Estimated Annual Reporting Burden for Animal Drugs
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and
abbreviated new animal drug applications (ANADAs); supplemental NADAs
and ANADAs (21 CFR 514.8(a)(1)); investigational new animal drug
applications and generic investigational new animal drug applications
(21 CFR 511.1(b)(10)); and food additive petitions (21 CFR 571.1(c))
must contain a claim for categorical exclusion under Sec. 25.30 or
Sec. 25.32 or an EA under Sec. 25.40. Annually, FDA's Center for
Veterinary Medicine has received approximately 1,140 claims for
categorical exclusion as required under Sec. 25.15(a) and (d) and 9
EAs as required under Sec. 25.40(a) and (c). Assuming an average of 10
claims per respondent, FDA estimates that approximately 114 respondents
will submit an average of 10 claims for categorical exclusion. FDA
further estimates that nine respondents will submit an average of one
EA. FDA estimates that it takes sponsors/applicants approximately 3
hours to prepare a claim of categorical exclusion and an average of
2,160 hours to prepare an EA. Based on recent numbers, we now estimate
a total of 22,860 hours for animal drugs (a decrease of 22,860 hours).
Table 4--Estimated Annual Reporting Burden for Animal Drugs \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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25.15(a) and (d)................ 114 10 1,140 3 3,420
[[Page 6875]]
25.40(a) and (c)................ 9 1 9 2,160 19,440
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Total....................... .............. .............. .............. .............. 22,860
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
VI. Estimated Annual Reporting Burden for Tobacco Products
Under sections 905, 910, and 911 of the Federal Food, Drug, and
Cosmetic 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 (MRTPAs) must contain a claim for categorical
exclusion or an EA. The majority of the EA burden for tobacco products
is covered under already existing information collections. The burden
for SEs is currently approved under OMB control number 0910-0673; the
burden for PMTAs are currently approved under OMB control number 0910-
0768; and the burden for SE exemptions are currently approved under OMB
control number 0910-0684.
FDA's estimates are based on actual report data from fiscal year
(FY) 2018 to FY 2020. On average, FDA estimated it received
approximately 14 MRTPAs from 14 respondents. Based on updated data for
this collection, FDA estimates 14 EAs from 14 respondents. A total of
14 respondents will submit an average of 1 application for
environmental assessment. Based on FDA's experience, previous
information provided by potential sponsors and knowledge that part of
the EA information has already been produced in one of the tobacco
product applications, FDA estimates that it takes approximately 80
hours to prepare an EA. Based on recent MRTPA numbers, we now estimate
a total of 14 annual responses and 1,120 hours for Tobacco Products (a
decrease of 13 responses and 1,040 hours).
Table 5--Estimated Annual Reporting Burden for Tobacco Products \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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25.40(a) and (c)................................................... 14 1 14 80 1,120
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Since the last OMB approval, we have adjusted our burden estimate.
We estimate the total burden for this information collection to be
30,315 annual responses, and 314,736 hours. These estimates reflect an
overall increase of 13,463 responses and 94,078 hours. We attribute the
adjustments to expected fluctuations in the number of responses the
various centers in FDA have received over the last few years.
Dated: February 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02475 Filed 2-4-22; 8:45 am]
BILLING CODE 4164-01-P
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