Agency Information Collection Activities; Proposed Collection; Comment Request; Environmental Impact Considerations, 26477-26481 [2018-12221]
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12217 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0781]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by July 9,
2018.
DATES:
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0428. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
ADDRESSES:
Record Retention Requirements for the
Soy Protein and Risk of Coronary Heart
Disease Health Claim—21 CFR 101.82
OMB Control Number 0910–0428—
Extension
Section 403(r)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
343(r)(3)(A)) provides for the use of food
label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health-related
condition only where that statement
meets the requirements of the
regulations issued by the Secretary of
Health and Human Services to authorize
the use of such a health claim. Section
101.82 (21 CFR 101.82) of our
regulations authorizes a health claim for
food labels about soy protein and the
risk of coronary heart disease.
Accordingly, FDA established the
previously referenced information
collection in support of the regulation.
In the Federal Register of October 31,
2017 (82 FR 50324), we published a
proposed rule to revoke the underlying
regulation found at § 101.82. We are
taking this action based on our review
of the totality of publicly available
scientific evidence currently available
and our tentative conclusion that such
evidence does not support our previous
determination that there is significant
scientific agreement among qualified
experts for a health claim regarding the
relationship between soy protein and
reduced risk of coronary heart disease.
Upon finalization of the proposed rule,
the associated information collection
requirements under this OMB control
number will be revoked. Until such time
and in accordance with the PRA, we
retain our currently approved burden
estimate for the information collection
displayed in table 1 of this notice.
In the Federal Register of March 8,
2018 (83 FR 9856), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
101.82(c)(2)(ii)(B) .................................................................
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1 There
Number of
records per
recordkeeper
25
Total
annual
records
Average
burden per
recordkeeping
1
25
Total
hours
1
25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our current experience with
the use of health claims, we estimate 25
firms market products bearing a soy
protein/coronary heart disease health
claim and that perhaps one of each
firm’s products might contain non-soy
sources of protein along with soy
protein. The records currently required
to be retained under § 101.82(c)(2)(ii)(B)
are the records, e.g., the formulation or
recipe, that a manufacturer has and
maintains as a normal course of its
doing business. Thus, the burden to the
food manufacturer is limited to
assembling and retaining the records,
which we estimate will take 1 hour
annually.
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Dated: May 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12216 Filed 6–6–18; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2012–N–0961]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Environmental
Impact Considerations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
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.’’
Submit either electronic or
written comments on the collection of
information by August 6, 2018.
DATES:
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.
ADDRESSES:
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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’’).
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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/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
PO 00000
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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
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
‘‘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 (§ 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 §§ 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
§ 25.30 or § 25.31, or an EA under
§ 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 § 25.15(a) and (d) and
10 EAs as required under § 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
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
3,724
10
4.1453
1
15,437
10
8
3,400
123,496
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
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Under § 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 § 25.30 or
§ 25.34 or an EA under § 25.40. In 2017,
FDA received an average of 50 claims
(original PMAs and supplements) for
categorical exclusions as required under
§ 25.15(a) and (d), and 0 EAs as required
under § 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
respondents
21 CFR section
25.15(a) and (d) ...................................................................
1 There
Number of
responses per
respondent
50
Total annual
responses
1
50
are no capital costs or operating and maintenance costs associated with this collection of information.
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Average
burden per
response
Total hours
6
300
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Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
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 (§ 312.23), NDAs (§ 314.50),
ANDAs (§ 314.94), and PMAs (§ 814.20)
must contain either a claim of
categorical exclusion under § 25.30 or
§ 25.32 or an EA under § 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 § 25.15(a) and (d)
annually and 2 EAs as required under
§ 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
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
247
2
2
1
494
2
8
3,400
3,952
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 § 25.30 or § 25.32 or an EA under
§ 25.40. Annually, FDA’s Center for
Veterinary Medicine has received
approximately 810 claims for categorical
exclusion as required under § 25.15(a)
and (d) and 22 EAs as required under
§ 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
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25.15(a) and (d) ...................................................................
25.40(a) and (c) ...................................................................
81
22
10
1
810
22
3
2,160
2,430
47,520
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
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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 § 25.40(a)
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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.
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TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of
respondents
21 CFR section
25.40(a) and (c) ...................................................................
1 There
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1860]
Advisory Committee; PulmonaryAllergy Drugs Advisory Committee,
Renewal
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Pulmonary-Allergy Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Pulmonary-Allergy
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until May 30, 2020.
DATES: Authority for the PulmonaryAllergy Drugs Advisory Committee will
expire on May 30, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug
SUMMARY:
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5,832
Total annual
responses
1
Average
burden per
response
5,832
Total hours
80
466,560
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.
AGENCY:
Number of
responses per
respondent
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Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002; 301–796–9001, email:
PADAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Pulmonary-Allergy Drugs Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of pulmonary
disease and diseases with allergic and/
or immunologic mechanisms and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
pulmonary medicine, allergy, clinical
immunology, and epidemiology or
statistics. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
CommitteesMeetingMaterials/Drugs/
Pulmonary-AllergyDrugsAdvisory
Committee/ucm107567.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12219 Filed 6–6–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0478]
Sebela Ireland, Ltd. et al.; Withdrawal
of Approval of 24 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on February 23, 2018. The
notice announced the voluntary
withdrawal of approval of 24
abbreviated new drug applications
(ANDAs) from multiple applicants,
effective March 26, 2018. The notice
indicated that FDA was withdrawing
approval of the following ANDA after
receiving a withdrawal request from
Sun Pharmaceutical Industries, Ltd., c/
o Sun Pharmaceutical Industries, Inc.
(Sun Pharmaceutical), 2 Independence
Way, Princeton, NJ 08540: ANDA
077483, Benazepril Hydrochloride and
Hydrochlorothiazide Tablets, 5
milligrams (mg)/6.25 mg, 10 mg/12.5
mg, 20 mg/12.5 mg, and 20 mg/25 mg.
Before withdrawal of this ANDA
became effective, however, Sun
SUMMARY:
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.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\
----------------------------------------------------------------------------------------------------------------
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
