[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63179-63182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26556]


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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) 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: Fax written comments on the collection of information by January 
7, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0322. 
Also include the FDA docket number found in 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

[[Page 63180]]

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) 
specifies the procedures for submitting to FDA a claim for a 
categorical exclusion. Extraordinary circumstances (Sec.  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) 
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 June 7, 2018 (83 FR 26477), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One PRA related comment was received.
    (Comment) One commenter requested that FDA should categorically 
exclude all categories of SE applications from the EA requirement.
    (Response) FDA appreciates this comment. We note, however, that any 
action to establish a categorial exclusion would need to be undertaken 
through a notice and comment rulemaking procedure.
    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 or 
Sec.  25.31, or an EA under Sec.  25.40. Annually, FDA receives 
approximately 3,687 INDs from 2,456 sponsors; 140 NDAs from 116 
applicants; 3,192 supplements to NDAs from 443 applicants; 28 biologic 
license applications (BLAs) from 22 applicants; 464 supplements to BLAs 
from 52 applicants; 1,152 ANDAs from 248 applicants; and 6,774 
supplements to ANDAs from 384 applicants. FDA estimates that it 
receives approximately 15,437 claims for categorical exclusions as 
required under Sec.  25.15(a) and (d) and 10 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.

                         Table 1--Estimated Annual Reporting Burden for Human Drugs \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15(a) and (d)................           3,724          4.1453          15,437               8         123,496
25.40(a) and (c)................              10               1              10           3,400          34,000
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    Total.......................  ..............  ..............  ..............  ..............         157,496
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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 
approvals (PMAs) (original PMAs and supplements) must contain a claim 
for categorical exclusion under Sec.  25.30 or Sec.  25.34 or an EA 
under Sec.  25.40. In 2017, FDA received an average of 50 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 50 respondents will 
submit an average of 1 application for

[[Page 63181]]

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.

                       Table 2--Estimated Annual Reporting Burden for Medical Devices \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15(a) and (d)................              50               1              50               6             300
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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 or an EA under Sec.  25.40. Annually, FDA receives 
approximately 34 BLAs from 18 applicants, 801 BLA supplements to 
license applications from 156 applicants, 345 INDs from 256 sponsors, 1 
NDA from 1 applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA 
from 1 applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3 
applicants, and 33 PMA supplements from 16 applicants. FDA estimates 
that approximately 10 percent of these supplements would be submitted 
with a claim for categorical exclusion or an EA.
    FDA has received approximately 481 claims for categorical exclusion 
as required under Sec.  25.15(a) and (d) annually and 2 EAs as required 
under Sec.  25.40(a) and (c) annually. Therefore, FDA estimates that 
approximately 247 respondents will submit an average of 2 applications 
for categorical exclusion and 2 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.

                     Table 3--Estimated Annual Reporting Burden for Biological Products \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15(a) and (d)................             247               2             494               8           3,952
25.40(a) and (c)................               2               1               2           3,400           6,800
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          10,752
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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); 21 CFR 514.8(a)(1) 
supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new 
animal drug applications (INADs) and generic investigational new animal 
drug applications (JINADs), and 21 CFR 571.1(c) food additive petitions 
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 810 claims for 
categorical exclusion as required under Sec.  25.15(a) and (d) and 22 
EAs as required under Sec.  25.40(a) and (c). Assuming an average of 10 
claims per respondent, FDA estimates that approximately 81 respondents 
will submit an average of 10 claims for categorical exclusion. FDA 
further estimates that 22 respondents will submit an average of 1 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.

                         Table 4--Estimated Annual Reporting Burden for Animal Drugs \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.15(a) and (d)................              81              10             810               3           2,430
25.40(a) and (c)................              22               1              22           2,160          47,520
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    Total.......................  ..............  ..............  ..............  ..............          49,950
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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 (PMTAs), SEs, Exemption from SEs, and modified risk tobacco 
products must contain a claim for categorical exclusion or an EA. After 
further review, the agency has concluded that the majority of the EA 
burden for tobacco products

[[Page 63182]]

is covered under already existing information collections. To avoid 
double counting, the agency has removed the burden which is approved 
under other FDA information collections. The burden for SEs are 
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) 2015 to FY 2017, on average FDA estimated it received 
approximately 27 modified risk tobacco product applications (MRTPAs) 
from 27 respondents. Based on updated data for this collection, FDA 
estimates 27 EAs from 27 respondents. A total of 27 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.

                       Table 5--Estimated Annual Reporting Burden for Tobacco Products \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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25.40(a) and (c)................              27               1              27              80           2,160
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The Estimated Annual Reporting Burden for Human Foods is no longer 
a part of this information collection. The burden has now been 
incorporated into OMB control number 0910-0541.
    Our estimated burden for the information collection reflects an 
overall decrease of 10,566 hours (currently approved 231,224) and a 
corresponding decrease of 11,364 annual responses (currently approved 
15,527). The new estimated totals are 220,658 hours and 4,163 annual 
responses. We attribute this adjustment to the removal of the majority 
tobacco burden from this collection, and the number of EA submissions 
we received since the last extension.

    Dated: November 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26556 Filed 12-6-18; 8:45 am]
 BILLING CODE 4164-01-P