[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26477-26481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12221]


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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 or Agency) is announcing 
an opportunity for public

[[Page 26478]]

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 the reporting requirements contained in the FDA 
collection of information ``Environmental Impact Considerations.''

DATES: Submit either electronic or written comments on the collection 
of information by August 6, 2018.

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 August 6, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of August 6, 2018. 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.
     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.gpo.gov/fdsys/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.

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. 3501-3520), 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--21 CFR Part 25

OMB Control Number 0910-0322--Extension

I. Background

    FDA is requesting OMB approval for the reporting requirements 
contained in the FDA collection of information

[[Page 26479]]

``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.
    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 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.


[[Page 26480]]

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
----------------------------------------------------------------------------------------------------------------
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. FDA's 
estimates are based on actual report data from fiscal year (FY) 2015 to 
FY 2017, on average FDA estimated it received approximately 260 
premarket review of new tobacco PMTAs from 260 respondents, 3,601 
provisional reports intended to demonstrate the substantial equivalence 
of a new tobacco product (SEs) from 3,601 respondents, 2,375 regular SE 
reports from 2,375 respondents, 101 exemption from substantial 
equivalence requirements applications (SE Exemptions) from 101 
respondents, and 27 modified risk tobacco product applications (MRTPAs) 
from 27 respondents. Based on updated data FDA estimates 5,832 EAs from 
5,832 respondents as required under Sec.  25.40(a) and (c). A total of 
5,832 respondents will submit an average of 1 application for 
environmental assessment. Part of the information in the EA will be 
developed while writing other parts of a PMTA, SE, Exemption from SE, 
or MRTPA. 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.

[[Page 26481]]



                       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)................           5,832               1           5,832              80         466,560
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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 increase of 453,834 hours (currently approved 231,224) and a 
corresponding increase of 7,108 annual responses (currently approved 
15,527). The new estimated totals are 685,058 hours and 22,635 annual 
responses. We attribute this adjustment to an increase in the number of 
EA submissions we received since the last extension.

    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12221 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P


