[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47501-47504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.

[[Page 47502]]

     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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.


[[Page 47504]]

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