[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]


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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 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, 
<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\
----------------------------------------------------------------------------------------------------------------
                                                     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  ..............  ..............  ..............  ..............
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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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
                                                     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
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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\
----------------------------------------------------------------------------------------------------------------
                                                     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
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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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         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
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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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