Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations, 6872-6875 [2022-02475]
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Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Total Section 904(c)(1) Reporting Burden Hours
jspears on DSK121TN23PROD with NOTICES1
1 There
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
19,193
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this collection of
information is estimated to be 19,193
hours. The burden estimate for this
collection of information includes the
time it will take to read the instructions,
test the products, and prepare the HPHC
report. In arriving at this burden
estimate, FDA estimated the number of
tobacco products to be reported under
the requirements of section 904(c)(1) of
the FD&C Act annually to FDA.
Section 1 of table 1 estimates that 424
respondents (380 cigarettes receiving
authorizations, 19 RYO tobacco
receiving authorizations, 25 smokeless
receiving authorizations) will submit
424 HPHC reports annually. Each
respondent represents a statutory
tobacco product that receives
authorization from FDA for which
manufacturers and importers (or their
agents), must report their product
information to FDA under section
904(c)(1) of the FD&C Act at least 90
days prior to delivery for introduction
into interstate commerce for all new
products. This section addresses the
time required to report their company
information to FDA through the use of
the electronic portal or paper forms.
The company information reported
includes company name; mailing
address; telephone and Fax numbers;
FDA Establishment Identifier number;
Data Universal Numbering System
number; and point of contact name,
mailing address, and telephone and Fax
numbers, as applicable. It also addresses
the time required for manufacturers and
importers to report their product
information by entering certain testing
information into the electronic or paper
forms.
The product information includes
brand and subbrand name; unique
product identification number; type of
product identification number; product
category and subcategory; and mean
weight and standard deviation of
tobacco in product.
We estimate that the burden to enter
both the company and product
information is no more than 1.82 hours
per response for cigarettes, 0.43 hours
per response for RYO, and 0.63 hours
per response for smokeless tobacco
products regardless of whether the
paper or electronic Form FDA series
3787 is used. The time to report per
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tobacco product types varies because
the number of HPHCs varies by tobacco
product category. The total hours
estimated for this section is 716.
The estimated number of responses
under section 904(c)(1) of the FD&C Act
is based on FDA’s experience, the past
4 years of tobacco products receiving
marketing authorizations from FDA, and
actual responses to FDA under this
provision of the FD&C Act for statutorily
regulated products.
Section 2 of table 1 estimates that 44
respondents (19 cigarette filler and RYO
tobacco receiving authorizations and 25
smokeless receiving authorizations) will
test quantities of HPHCs in an average
of 44 products annually. This section
addresses the time required for
manufacturers and importers (or their
agents) who must test HPHC quantities
in products. The burden estimates
include the burden to test the tobacco
products, draft testing reports, and
submit the report to FDA. The total
expected burden for this section is 481
hours.
Section 3 of table 1 addresses the time
required for manufacturers and
importers to test quantities for HPHCs in
cigarette smoke. The burden estimates
include: The burden to test the number
of replicate measurements; test date
range; manufacture date range;
extraction method; separation method;
detection method; and mean quantity
and standard deviation of HPHCs and
includes the burden to test the tobacco
products, draft testing reports, and
submit the report to FDA. The annual
burden reflects our estimate of the time
it takes to test the tobacco products (i.e.,
carry out laboratory work). The burden
estimate assumes that manufacturers
and importers report HPHC quantities in
cigarette mainstream smoke according
to the two smoking regimens. The total
expected burden is 17,996 hours for this
section.
The total estimated burden for this
information collection is 19,193 hours
and 424 respondents. Our estimated
burden for the information collection
reflects an overall increase of 269
respondents and a corresponding
increase of 16,677 hours. We attribute
this adjustment to updated methodology
in which the current estimates are
derived from historical statutory tobacco
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product applications submitted and
authorized by FDA in the past 4 years
as (1) manufacturers and importers (or
their agents) of authorized products are
required to submit HPHC reports at least
90 days prior to delivery for
introduction into interstate commerce
for all new products and (2) initial
reporting under section 904(a)(3) of the
FD&C Act for statutory products was
completed in 2012.
Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02478 Filed 2–4–22; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
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
ADDRESSES:
E:\FR\FM\07FEN1.SGM
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6873
Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
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, PRAStaff@
fda.hhs.gov.
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 §§ 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
§ 25.30 (21 CFR 25.30) or § 25.31 (21
CFR 25.31), or an EA under § 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 § 25.15(a) and (d) and
13 EAs as required under § 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
Number of
respondents
jspears on DSK121TN23PROD with NOTICES1
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
5,186
14
4.2273
0.9285
21,923
13
8
3,400
175,384
44,200
Total ..............................................................................
219,584
........................
........................
........................
........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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III. Estimated Annual Reporting
Burden for Medical Devices
Under § 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 § 25.30 or
21 CFR 25.34 or an EA under § 25.40.
In 2020, FDA received an average of 62
claims (original PMAs and
supplements) for categorical exclusions
as required under § 25.15(a) and (d), and
0 EAs as required under § 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
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden
per
response
Total hours
25.15(a) and (d) ...................................................................
62
1
62
6
372
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 (§ 312.23), NDAs (§ 314.50),
ANDAs (§ 314.94), and PMAs (§ 814.20)
must contain either a claim of
categorical exclusion under § 25.30 or
§ 25.32 (21 CFR 25.32) or an EA under
§ 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
§ 25.15(a) and (d) annually and 4 EAs as
required under § 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
Number of
respondents
21 CFR section
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
3,575
4
2
1
7,150
4
8
3,400
57,200
13,600
Total ..............................................................................
........................
........................
........................
........................
70,800
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
jspears on DSK121TN23PROD with NOTICES1
Number of
responses per
respondent
food additive petitions (21 CFR 571.1(c))
must contain a claim for categorical
exclusion under § 25.30 or § 25.32 or an
EA under § 25.40. Annually, FDA’s
Center for Veterinary Medicine has
received approximately 1,140 claims for
categorical exclusion as required under
§ 25.15(a) and (d) and 9 EAs as required
under § 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
Number of
respondents
21 CFR section
25.15(a) and (d) ...................................................................
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Number of
responses per
respondent
114
Fmt 4703
Sfmt 4703
Total annual
responses
10
E:\FR\FM\07FEN1.SGM
1,140
07FEN1
Average
burden per
response
Total hours
3
3,420
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Federal Register / Vol. 87, No. 25 / Monday, February 7, 2022 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
25.40(a) and (c) ...................................................................
9
1
9
2,160
19,440
Total ..............................................................................
........................
........................
........................
........................
22,860
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
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.40(a) and (c) ...................................................................
14
1
14
80
1,120
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0053]
Notifying the Food and Drug
Administration of a Permanent
Discontinuance or Interruption in
Manufacturing of a Device Under
Section 506J of the Federal Food,
Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability;
Extension of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; extension
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
extending the comment period for the
notice of availability that appeared in
the Federal Register of January 11,
2022. In the notice of availability, FDA
requested comments on draft guidance
for industry and FDA staff entitled
‘‘Notifying the Food and Drug
Administration of a Permanent
Discontinuance or Interruption in
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
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Manufacturing of a Device Under
Section 506J of the Federal Food, Drug,
and Cosmetic Act.’’ The Agency is
taking this action in response to a
request for an extension to allow
interested persons additional time to
submit comments.
DATES: FDA is extending the comment
period on the document published
January 11, 2022 (87 FR 1417). Submit
either electronic or written comments
on the draft guidance by April 11, 2022,
to ensure that the Agency considers
your comment on this draft guidance
before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
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]]>Agencies
[Federal Register Volume 87, Number 25 (Monday, February 7, 2022)]
[Notices]
[Pages 6872-6875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02475]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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
[[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,
[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--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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... 219,584 .............. .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.15(a) and (d)................................................... 62 1 62 6 372
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 70,800
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 22,860
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
25.40(a) and (c)................................................... 14 1 14 80 1,120
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
