Notice2021-18239
Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations
Primary source
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Published
August 25, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 "Environmental Impact Considerations."
Full Text
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<title>Federal Register, Volume 86 Issue 162 (Wednesday, August 25, 2021)</title>
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[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47501-47504]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18239]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0961]
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, Agency, or we) 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 ``Environmental Impact
Considerations.''
DATES: Submit either electronic or written comments on the collection
of information by October 25, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 25, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 25, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2012-N-0961 for ``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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
[[Page 47502]]
<bullet> 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
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#bceceefdefc8dddadafcdad8dd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="0c5c5e4d5f786d6a6a4c6a686d2264647f226b637a">[email protected]</span></a>.
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
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. In Sec. 25.15(a) and (d) (21 CFR
25.15(a) and (d)) the procedures for submitting to FDA a claim for a
categorical exclusion are specified. Extraordinary circumstances (under
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.
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
[[Page 47503]]
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.
III. Estimated Annual Reporting Burden for Medical Devices
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 categorical exclusion under Sec. 25.30 or Sec.
25.34 (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 biological products (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.
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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 (INADs) and generic investigational new animal drug
applications (JINADs) (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 27,090 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
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
equivalence (SE), exemption from SE, 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; 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 one 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.
FDA estimates the 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. These
adjustments are attributed to an increase in the number of responses
the various centers in FDA have received over the last few years.
Dated: August 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18239 Filed 8-24-21; 8:45 am]
BILLING CODE 4164-01-P
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