83 FR 26477 - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 110 (June 7, 2018)

Page Range		26477-26481
FR Document		2018-12221

The Food and Drug Administration (FDA or Agency) 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 the reporting requirements contained in the FDA collection of information ``Environmental Impact Considerations.''

Federal Register, Volume 83 Issue 110 (Thursday, June 7, 2018)

[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26477-26481]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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\
----------------------------------------------------------------------------------------------------------------
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)................ 3,724 4.1453 15,437 8 123,496
25.40(a) and (c)................ 10 1 10 3,400 34,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 157,496
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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)................ 50 1 50 6 300
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
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)................ 81 10 810 3 2,430
25.40(a) and (c)................ 22 1 22 2,160 47,520
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 49,950
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
25.40(a) and (c)................ 5,832 1 5,832 80 466,560
----------------------------------------------------------------------------------------------------------------
\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

Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26477

GuidanceComplianceRegulatory ADDRESSES: To ensure that comments on regulations issued by the Secretary of
Information/Guidances/default.htm or the information collection are received, Health and Human Services to authorize
https://www.regulations.gov. OMB recommends that written the use of such a health claim. Section
Dated: June 1, 2018. comments be faxed to the Office of 101.82 (21 CFR 101.82) of our
Leslie Kux,
Information and Regulatory Affairs, regulations authorizes a health claim for
OMB, Attn: FDA Desk Officer, Fax: 202– food labels about soy protein and the
Associate Commissioner for Policy.
395–7285, or emailed to oira_ risk of coronary heart disease.
[FR Doc. 2018–12217 Filed 6–6–18; 8:45 am] submission@omb.eop.gov. All Accordingly, FDA established the
BILLING CODE 4164–01–P comments should be identified with the previously referenced information
OMB control number 0910–0428. Also collection in support of the regulation.
include the FDA docket number found In the Federal Register of October 31,
DEPARTMENT OF HEALTH AND in brackets in the heading of this 2017 (82 FR 50324), we published a
HUMAN SERVICES document. proposed rule to revoke the underlying
Food and Drug Administration FOR FURTHER INFORMATION CONTACT: regulation found at § 101.82. We are
JonnaLynn Capezzuto, Office of taking this action based on our review
Operations, Food and Drug of the totality of publicly available
[Docket No. FDA–2011–N–0781]
Administration, Three White Flint scientific evidence currently available
Agency Information Collection North, 10A–12M, 11601 Landsdown St., and our tentative conclusion that such
Activities; Submission for Office of North Bethesda, MD 20852, 301–796– evidence does not support our previous
Management and Budget Review; 3794, PRAStaff@fda.hhs.gov. determination that there is significant
Comment Request; Record Retention SUPPLEMENTARY INFORMATION: In scientific agreement among qualified
Requirements for the Soy Protein and compliance with 44 U.S.C. 3507, FDA experts for a health claim regarding the
Risk of Coronary Heart Disease Health has submitted the following proposed relationship between soy protein and
Claim collection of information to OMB for reduced risk of coronary heart disease.
review and clearance. Upon finalization of the proposed rule,
AGENCY: Food and Drug Administration, the associated information collection
HHS. Record Retention Requirements for the requirements under this OMB control
Soy Protein and Risk of Coronary Heart number will be revoked. Until such time
ACTION: Notice. Disease Health Claim—21 CFR 101.82 and in accordance with the PRA, we
SUMMARY: The Food and Drug OMB Control Number 0910–0428— retain our currently approved burden
Administration (FDA) is announcing Extension estimate for the information collection
that a proposed collection of displayed in table 1 of this notice.
Section 403(r)(3)(A) of the Federal
information has been submitted to the In the Federal Register of March 8,
Food, Drug, and Cosmetic Act (21 U.S.C.
Office of Management and Budget 2018 (83 FR 9856), FDA published a 60-
343(r)(3)(A)) provides for the use of food
(OMB) for review and clearance under day notice requesting public comment
label statements characterizing a
the Paperwork Reduction Act of 1995 relationship of any nutrient of the type on the proposed collection of
(PRA). required to be in the label or labeling of information. No comments were
DATES: Fax written comments on the the food to a disease or a health-related received.
collection of information by July 9, condition only where that statement FDA estimates the burden of this
2018. meets the requirements of the collection of information as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Total Average
Number of Total
21 CFR section records per annual burden per
recordkeepers hours
recordkeeper records recordkeeping

101.82(c)(2)(ii)(B) ................................................................. 25 1 25 1 25
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on our current experience with Dated: May 30, 2018. DEPARTMENT OF HEALTH AND
the use of health claims, we estimate 25 Leslie Kux, HUMAN SERVICES
firms market products bearing a soy Associate Commissioner for Policy.
protein/coronary heart disease health Food and Drug Administration
[FR Doc. 2018–12216 Filed 6–6–18; 8:45 am]
claim and that perhaps one of each BILLING CODE 4164–01–P [Docket No. FDA–2012–N–0961]
firm’s products might contain non-soy
sources of protein along with soy Agency Information Collection
protein. The records currently required Activities; Proposed Collection;
to be retained under § 101.82(c)(2)(ii)(B) Comment Request; Environmental
are the records, e.g., the formulation or Impact Considerations
sradovich on DSK3GMQ082PROD with NOTICES

recipe, that a manufacturer has and AGENCY: Food and Drug Administration,
maintains as a normal course of its HHS.
doing business. Thus, the burden to the ACTION: Notice.
food manufacturer is limited to
assembling and retaining the records, SUMMARY: The Food and Drug
which we estimate will take 1 hour Administration (FDA or Agency) is
annually. announcing an opportunity for public

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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26479

‘‘Environmental Impact This collection of information is used are expected, the Agency prepares a
Considerations.’’ The National by FDA to assess the environmental finding of no significant impact.
Environmental Policy Act (NEPA) (42 impact of Agency actions and to ensure FDA estimates the burden of this
U.S.C. 4321–4347) states national that the public is informed of collection of information as follows:
environmental objectives and imposes environmental analyses. Firms wishing
II. Estimated Annual Reporting Burden
upon each Federal Agency the duty to to manufacture and market substances
for Human Drugs (Including Biologics
consider the environmental effects of its regulated under statutes for which FDA
in the Center for Drug Evaluation and
actions. Section 102(2)(C) of NEPA is responsible must, in most instances,
Research)
requires the preparation of an submit applications requesting
environmental impact statement (EIS) approval. Environmental information Under §§ 312.23(a)(7)(iv)(e),
for every major Federal action that will must be included in such applications 314.50(d)(1)(iii), and 314.94(a)(9)(i) (21
significantly affect the quality of the for the purpose of determining whether CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii),
human environment. the proposed action may have a and 314.94(a)(9)(i)), each investigational
significant impact on the environment. new drug application (IND), new drug
FDA’s NEPA regulations are in part 25 Where significant adverse events cannot application (NDA), and abbreviated new
(21 CFR part 25). All applications or be avoided, the Agency uses the drug application (ANDA) must contain
petitions requesting Agency action submitted information as the basis for a claim for categorical exclusion under
require the submission of a claim for preparing and circulating to the public § 25.30 or § 25.31, or an EA under
categorical exclusion or an an EIS, made available through a § 25.40. Annually, FDA receives
environmental assessment (EA). A Federal Register document also filed for approximately 3,687 INDs from 2,456
categorical exclusion applies to certain comment at the Environmental sponsors; 140 NDAs from 116
classes of FDA-regulated actions that Protection Agency. The final EIS, applicants; 3,192 supplements to NDAs
usually have little or no potential to including the comments received, is from 443 applicants; 28 biologic license
cause significant environmental effects reviewed by the Agency to weigh applications (BLAs) from 22 applicants;
and are excluded from the requirements environmental costs and benefits in 464 supplements to BLAs from 52
to prepare an EA or EIS. Section determining whether to pursue the applicants; 1,152 ANDAs from 248
25.15(a) and (d) specifies the procedures proposed action or some alternative that applicants; and 6,774 supplements to
for submitting to FDA a claim for a would reduce expected environmental ANDAs from 384 applicants. FDA
categorical exclusion. Extraordinary impact. estimates that it receives approximately
circumstances (§ 25.21), which may Any final EIS would contain 15,437 claims for categorical exclusions
result in significant environmental additional information gathered by the as required under § 25.15(a) and (d) and
impacts, may exist for some actions that Agency after the publication of the draft 10 EAs as required under § 25.40(a) and
are usually categorically excluded. An EIS, a copy or a summary of the (c). Based on information provided by
EA provides information that is used to comments received on the draft EIS, and the pharmaceutical industry, FDA
determine whether an FDA action could the Agency’s responses to the estimates that it takes sponsors or
result in a significant environmental comments, including any revisions applicants approximately 8 hours to
impact. Section 25.40(a) and (c) resulting from the comments or other prepare a claim for a categorical
specifies the content requirements for information. When the Agency finds exclusion and approximately 3,400
EAs for non-excluded actions. that no significant environmental effects hours to prepare an EA.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

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

Total .............................................................................. ........................ ........................ ........................ ........................ 157,496
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Estimated Annual Reporting categorical exclusion under § 25.30 or that approximately 50 respondents will
Burden for Medical Devices § 25.34 or an EA under § 25.40. In 2017, submit an average of 1 application for
FDA received an average of 50 claims categorical exclusion annually. Based
Under § 814.20(b)(11) (21 CFR (original PMAs and supplements) for on information provided by sponsors,
814.20(b)(11)), premarket approvals categorical exclusions as required under FDA estimates that it takes
(PMAs) (original PMAs and § 25.15(a) and (d), and 0 EAs as required approximately 6 hours to prepare a
supplements) must contain a claim for under § 25.40(a) and (c). FDA estimates claim for a categorical exclusion.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES 1
sradovich on DSK3GMQ082PROD with NOTICES

Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

25.15(a) and (d) ................................................................... 50 1 50 6 300
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

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26480 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices

IV. Estimated Annual Reporting Burden from 156 applicants, 345 INDs from 256 annually and 2 EAs as required under
for Biological Products, Drugs, and sponsors, 1 NDA from 1 applicant, 26 § 25.40(a) and (c) annually. Therefore,
Medical Devices in the Center for supplements to NDAs from 8 applicants, FDA estimates that approximately 247
Biologics Evaluation and Research 1 ANDA from 1 applicant, 1 supplement respondents will submit an average of 2
to ANDAs from 1 applicant, 8 PMAs applications for categorical exclusion
Under 21 CFR 601.2(a), BLAs as well from 3 applicants, and 33 PMA and 2 respondents will submit an
as INDs (§ 312.23), NDAs (§ 314.50), supplements from 16 applicants. FDA average of 1 EA. Based on information
ANDAs (§ 314.94), and PMAs (§ 814.20) estimates that approximately 10 percent provided by industry, FDA estimates
must contain either a claim of of these supplements would be that it takes sponsors and applicants
categorical exclusion under § 25.30 or submitted with a claim for categorical
§ 25.32 or an EA under § 25.40. approximately 8 hours to prepare a
exclusion or an EA.
Annually, FDA receives approximately FDA has received approximately 481 claim of categorical exclusion and
34 BLAs from 18 applicants, 801 BLA claims for categorical exclusion as approximately 3,400 hours to prepare an
supplements to license applications required under § 25.15(a) and (d) EA for a biological product.

TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent 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
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

V. Estimated Annual Reporting Burden investigational new animal drug of 10 claims per respondent, FDA
for Animal Drugs applications (JINADs), and 21 CFR estimates that approximately 81
571.1(c) food additive petitions must respondents will submit an average of
Under 21 CFR 514.1(b)(14), new contain a claim for categorical exclusion 10 claims for categorical exclusion. FDA
animal drug applications (NADAs) and under § 25.30 or § 25.32 or an EA under further estimates that 22 respondents
abbreviated new animal drug § 25.40. Annually, FDA’s Center for will submit an average of 1 EA. FDA
applications (ANADAs); 21 CFR Veterinary Medicine has received estimates that it takes sponsors/
514.8(a)(1) supplemental NADAs and approximately 810 claims for categorical applicants approximately 3 hours to
ANADAs; 21 CFR 511.1(b)(10) exclusion as required under § 25.15(a) prepare a claim of categorical exclusion
investigational new animal drug and (d) and 22 EAs as required under and an average of 2,160 hours to prepare
applications (INADs) and generic § 25.40(a) and (c). Assuming an average an EA.

TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

25.15(a) and (d) ................................................................... 81 10 810 3 2,430
25.40(a) and (c) ................................................................... 22 1 22 2,160 47,520

Total .............................................................................. ........................ ........................ ........................ ........................ 49,950
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

VI. Estimated Annual Reporting Burden PMTAs from 260 respondents, 3,601 and (c). A total of 5,832 respondents
for Tobacco Products provisional reports intended to will submit an average of 1 application
Under sections 905, 910, and 911 of demonstrate the substantial equivalence for environmental assessment. Part of
the Federal Food, Drug, and Cosmetic of a new tobacco product (SEs) from the information in the EA will be
Act (21 U.S.C. 387e, 387j, and 387k), 3,601 respondents, 2,375 regular SE developed while writing other parts of
product applications and supplements reports from 2,375 respondents, 101 a PMTA, SE, Exemption from SE, or
(PMTAs), SEs, Exemption from SEs, and exemption from substantial equivalence MRTPA. Based on FDA’s experience,
modified risk tobacco products must requirements applications (SE previous information provided by
contain a claim for categorical exclusion Exemptions) from 101 respondents, and potential sponsors and knowledge that
or an EA. FDA’s estimates are based on 27 modified risk tobacco product part of the EA information has already
sradovich on DSK3GMQ082PROD with NOTICES

actual report data from fiscal year (FY) applications (MRTPAs) from 27 been produced in one of the tobacco
2015 to FY 2017, on average FDA respondents. Based on updated data product applications, FDA estimates
estimated it received approximately 260 FDA estimates 5,832 EAs from 5,832 that it takes approximately 80 hours to
premarket review of new tobacco respondents as required under § 25.40(a) prepare an EA.

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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26481

TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

25.40(a) and (c) ................................................................... 5,832 1 5,832 80 466,560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The Estimated Annual Reporting Administration, 10903 New Hampshire CommitteesMeetingMaterials/Drugs/
Burden for Human Foods is no longer a Ave., Bldg. 31, Rm. 2417, Silver Spring, Pulmonary-AllergyDrugsAdvisory
part of this information collection. The MD 20993–0002; 301–796–9001, email: Committee/ucm107567.htm or by
burden has now been incorporated into PADAC@fda.hhs.gov. contacting the Designated Federal
OMB control number 0910–0541. SUPPLEMENTARY INFORMATION: Pursuant Officer (see FOR FURTHER INFORMATION
Our estimated burden for the to 41 CFR 102–3.65 and approval by the CONTACT). In light of the fact that no
information collection reflects an Department of Health and Human change has been made to the committee
overall increase of 453,834 hours Services pursuant to 45 CFR part 11 and name or description of duties, no
(currently approved 231,224) and a by the General Services Administration, amendment will be made to 21 CFR
corresponding increase of 7,108 annual FDA is announcing the renewal of the 14.100.
responses (currently approved 15,527). Pulmonary-Allergy Drugs Advisory This document is issued under the
The new estimated totals are 685,058 Committee (the Committee). The Federal Advisory Committee Act (5
hours and 22,635 annual responses. We Committee is a discretionary Federal U.S.C. app.). For general information
attribute this adjustment to an increase advisory committee established to related to FDA advisory committees,
in the number of EA submissions we provide advice to the Commissioner. please check https://www.fda.gov/
received since the last extension. The Committee advises the AdvisoryCommittees/default.htm.
Dated: June 1, 2018.
Commissioner or designee in Dated: June 1, 2018.
discharging responsibilities as they Leslie Kux,
Leslie Kux,
relate to helping to ensure safe and
Associate Commissioner for Policy. Associate Commissioner for Policy.
effective drugs for human use and, as
[FR Doc. 2018–12221 Filed 6–6–18; 8:45 am] [FR Doc. 2018–12219 Filed 6–6–18; 8:45 am]
required, any other product for which
BILLING CODE 4164–01–P
BILLING CODE 4164–01–P FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
effectiveness of marketed and
HUMAN SERVICES HUMAN SERVICES
investigational human drug products for
use in the treatment of pulmonary Food and Drug Administration
Food and Drug Administration
disease and diseases with allergic and/
[Docket No. FDA–2018–N–1860] or immunologic mechanisms and makes [Docket No. FDA–2018–N–0478]
appropriate recommendations to the
Advisory Committee; Pulmonary- Commissioner of Food and Drugs. Sebela Ireland, Ltd. et al.; Withdrawal
Allergy Drugs Advisory Committee, The Committee shall consist of a core of Approval of 24 Abbreviated New
Renewal of 11 voting members including the Drug Applications; Correction
Chair. Members and the Chair are AGENCY: Food and Drug Administration,
AGENCY: Food and Drug Administration, selected by the Commissioner or
HHS. HHS.
designee from among authorities ACTION: Notice; correction.
ACTION:Notice; renewal of advisory knowledgeable in the fields of
committee. pulmonary medicine, allergy, clinical SUMMARY: The Food and Drug
immunology, and epidemiology or Administration (FDA) is correcting a
SUMMARY: The Food and Drug notice that appeared in the Federal
statistics. Members will be invited to
Administration (FDA) is announcing the Register on February 23, 2018. The
serve for overlapping terms of up to 4
renewal of the Pulmonary-Allergy Drugs notice announced the voluntary
years. Almost all non-Federal members
Advisory Committee by the withdrawal of approval of 24
of this committee serve as Special
Commissioner of Food and Drugs (the abbreviated new drug applications
Government Employees. The core of
Commissioner). The Commissioner has (ANDAs) from multiple applicants,
voting members may include one
determined that it is in the public effective March 26, 2018. The notice
technically qualified member, selected
interest to renew the Pulmonary-Allergy indicated that FDA was withdrawing
by the Commissioner or designee, who
Drugs Advisory Committee for an approval of the following ANDA after
is identified with consumer interests
additional 2 years beyond the charter receiving a withdrawal request from
and is recommended by either a
expiration date. The new charter will be Sun Pharmaceutical Industries, Ltd., c/
consortium of consumer-oriented
in effect until May 30, 2020. o Sun Pharmaceutical Industries, Inc.
organizations or other interested
DATES: Authority for the Pulmonary- (Sun Pharmaceutical), 2 Independence
sradovich on DSK3GMQ082PROD with NOTICES

persons. In addition to the voting
Allergy Drugs Advisory Committee will members, the Committee may include Way, Princeton, NJ 08540: ANDA
expire on May 30, 2020, unless the one non-voting member who is 077483, Benazepril Hydrochloride and
Commissioner formally determines that identified with industry interests. Hydrochlorothiazide Tablets, 5
renewal is in the public interest. Further information regarding the milligrams (mg)/6.25 mg, 10 mg/12.5
FOR FURTHER INFORMATION CONTACT: most recent charter and other mg, 20 mg/12.5 mg, and 20 mg/25 mg.
Cindy Chee, Center for Drug Evaluation information can be found at https:// Before withdrawal of this ANDA
and Research, Food and Drug www.fda.gov/AdvisoryCommittees/ became effective, however, Sun

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Document Created: 2018-06-07 00:50:10
Document Modified: 2018-06-07 00:50:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by August 6, 2018.
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]
FR Citation		83 FR 26477

83 FR 26477 - Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 110 (June 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration