Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug, 58403-58407 [2017-26670]
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information is missing. The ambulance
provider/supplier or beneficiary can
rectify the error(s) and resubmit the
prior authorization request with
appropriate documentation.
• Scenario 4: If an ambulance
provider or supplier renders a service to
a beneficiary and does not request prior
authorization by the fourth round trip in
a 30-day period, and the claim is
submitted to the MAC for payment, then
the claim will be stopped for
prepayment review and documentation
will be requested.
++ If the claim is determined to be for
services that were not medically
necessary or for which there was
insufficient documentation, the claim
will be denied, and all current policies
and procedures regarding liability for
payment will apply. The ambulance
provider/supplier or the beneficiary, or
both, can appeal the claim denial if they
believe the denial was inappropriate.
++ If the claim is determined to be
payable, it will be paid.
Under the model, we will work to
limit any adverse impact on
beneficiaries and to educate
beneficiaries about the process. If a prior
authorization request is non-affirmed,
and the claim is still submitted by the
ambulance provider/supplier, the claim
will be denied, but beneficiaries will
continue to have all applicable
administrative appeal rights. We will
also work to implement a process that
will help identify alternate
transportation resources for
beneficiaries who receive nonaffirmative decisions.
Only one prior authorization request
per beneficiary per designated time
period can be provisionally affirmed. If
the initial ambulance provider/supplier
cannot complete the total number of
prior authorized transports (for
example, the initial ambulance
company closes or no longer services
that area), the initial request is
cancelled. In this situation, a
subsequent prior authorization request
may be submitted for the same
beneficiary and must include the
required documentation in the
submission. If multiple ambulance
providers/suppliers are providing
transports to the beneficiary during the
same or overlapping time period, the
prior authorization decision will only
cover the ambulance provider/supplier
indicated in the provisionally affirmed
prior authorization request. Any
ambulance provider/supplier submitting
claims for repetitive, scheduled nonemergent ambulance transports for
which no prior authorization request is
submitted by the fourth round trip in a
30-day period will be subject to 100
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percent prepayment medical review of
those claims.
Additional information is available on
the CMS website at https://go.cms.gov/
PAAmbulance.
III. Collection of Information
Requirements
Section 1115A(d)(3) of the Act states
that chapter 35 of title 44, United States
Code (the Paperwork Reduction Act of
1995), shall not apply to the testing and
evaluation of models or expansion of
such models under this section.
Consequently, this document need not
be reviewed by the Office of
Management and Budget under the
authority of the Paperwork Reduction
Act of 1995.
IV. Regulatory Impact Statement
This document announces a 1-year
extension of the Medicare Prior
Authorization Model for Repetitive
Scheduled Non-Emergent Ambulance
Transport. Therefore, there are no
regulatory impact implications
associated with this notice.
Authority: Section 1115A of the Social
Security Act.
Dated: November 16, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2017–26759 Filed 12–8–17; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0523]
Agency Information Collection
Activities: Submission for Office of
Management and Budget Review;
Comment Request; Applications for
Food and Drug Administration
Approval To Market a New Drug
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.
DATES: Fax written comments on the
collection of information by January 11,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
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58403
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 0910–0001. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Application for FDA Approval To
Market a New Drug
OMB Control Number 0910–0001—
Extension
Under section 505(a) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 355(a)), a new
drug may not be commercially marketed
in the United States, imported, or
exported from the United States, unless
an approval of an application filed with
FDA under section 505(b) or (j) of the
FD&C Act is effective with respect to
such drug. The Agency has codified
regulations regarding applications for
FDA approval to market a new drug
under 21 CFR part 314. This collection
of information supports the regulatory
requirements found in those regulations.
The collection of information is
necessary for FDA to make a scientific
and technical determination whether
the product is safe and effective for use,
and is summarized as follows:
Section 314.50(a) requires that an
application form (Form FDA 356h) be
submitted that includes information
about the applicant, the submission, and
a checklist of enclosures.
Section 314.50(b) requires that an
index be submitted with the archival
copy of the application and that it
reference certain sections of the
application.
Section 314.50(c) requires that a
summary of the application be
submitted that presents a good general
synopsis of all the technical sections
and other information in the
application.
Section 314.50(d) requires that the
new drug application (NDA) contain the
following technical sections about the
new drug: Chemistry, manufacturing,
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and controls; nonclinical pharmacology
and toxicology; human
pharmacokinetics and bioavailability;
microbiology; clinical data; statistical;
and pediatric use sections.
Section 314.50(e) requires the
applicant to submit samples of the drug
if requested by FDA. In addition, the
archival copy of the application must
include copies of the label and all
labeling for the drug.
Section 314.50(f) requires that case
report forms and tabulations be
submitted with the archival copy.
Section 314.50(h) requires that patent
information, as described under
§ 314.53, be submitted with the
application. However, burden hours for
§ 314.50(h) are approved under OMB
control numbers 0910–0513 (Patent
Certification Forms FDA 3542 and FDA
3542a) and 0910–0786 (Abbreviated
New Drug Applications (ANDAs) and
505(b)(2) Applications), and are
therefore not included among the
estimates found in table 1.
Section 314.50(i) requires that patent
certification information be submitted
in section 505(b)(2) applications for
patents claiming the drug substance,
drug product, or method of use.
Sections 314.50(i)(1)(i)(C) and 314.54(i)
and (j) require that patent certification
information be submitted for each
patent listed in the ‘‘Approved Drug
Products with Therapeutic Equivalence
Evaluations’’ (the Orange Book) for a
drug product approved in an NDA that
is pharmaceutically equivalent to the
proposed drug product in the original
505(b)(2) application and was submitted
and was approved before the original
505(b)(2) application was submitted.
Burden for these provisions is included
under OMB control number 0910–0786.
Section 314.50(j) requires that
applicants who request a period of
marketing exclusivity submit certain
information with the application.
Section 314.50(k) requires that the
application contain a financial
certification or disclosure statement or
both.
Section 314.50(l) requires that an
archival, review, and field copy of the
application be submitted, including the
content of labeling and all labeling and
labels.
Section 314.52 requires that any
notice of certification of invalidity,
unenforceability, or non-infringement of
a patent to each patent owner and the
NDA holder be sent by a section
505(b)(2) applicant that relies on a listed
drug. A 505(b)(2) applicant is required
to amend the application at the time
notice is provided to include a
statement certifying that the required
notice has been provided. A 505(b)(2)
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applicant also is required to amend the
application to document receipt of the
required notice. Burden hours for these
provisions are included in OMB control
number 0910–0786.
Section 314.53 sets forth the patent
information requirements for applicants
who submit applications or
amendments to the application filed
under section 505(b)(2) of the FD&C Act
or supplements to the approved
505(b)(2) application. Burden hours for
these collections are approved in OMB
control number 0910–0786.
Section 314.54 sets forth the content
requirements for applications filed
under section 505(b)(2) of the FD&C Act.
The burden estimate for 505(b)(2)
applications is included in table 1 under
the estimates for § 314.50(a) through (g)
and (i) through (l).
Section 314.55 sets forth the
assessment requirements for each
application. The burden estimate for
505(b)(2) applications is included in
table 1 under the estimates for
§ 314.50(a) through (g) and (i) through
(l).
Section 314.60 sets forth reporting
requirements and patent certification
requirements for sponsors who amend
an unapproved 505(b)(2) application.
Burden hours for the § 314.60(f)
collections are approved under OMB
control number 0910–0786.
Section 314.65 states that the sponsor
must notify FDA when withdrawing an
unapproved application.
Sections 314.70 and 314.71 require
that supplements be submitted to FDA
for certain changes to an approved
application.
Section 314.72 requires sponsors to
report to FDA any transfer of ownership
of an application.
Section 314.80(c)(1) and (2) set forth
requirements for expedited adverse drug
experience postmarketing reports and
followup reports, as well as for periodic
adverse drug experience postmarketing
reports (Form FDA 3500A).
Section 314.80(i) establishes
recordkeeping requirements for reports
of postmarketing adverse drug
experiences. The burden hours for
§ 314.80(i) are approved under OMB
control numbers 0910–0230 (Adverse
Drug Experience Reporting) and 0910–
0291 (MedWatch: FDA’s Medical
Reporting Program), and therefore
burden estimates are not included in
table 1.
Section 314.81(b)(1) requires that
NDA and ANDA field alert reports be
submitted to FDA (Forms FDA 3331 and
Form FDA 3331a).
Section 314.81(b)(2) requires that
annual reports be submitted to FDA
(Form FDA 2252).
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Section 314.81(b)(3)(i) requires that
drug advertisements and promotional
labeling be submitted to FDA (Form
FDA 2253).
Section 314.81(b)(3)(iii) sets forth
reporting requirements for sponsors
who withdraw an approved drug
product from sale. The burden hours for
§ 314.81(b)(3)(iii) are approved under
OMB control number 0910–0045
(Registration of Producers of Drugs and
Listing of Drugs in Commercial
Distribution), and therefore are not
included in table 1.
Section 314.90 sets forth requirements
for sponsors who request waivers from
FDA for compliance with §§ 314.50
through 314.81. The information
collection burden estimate for NDA
waiver requests is included in table 1
under the estimates for each section that
is in part 314, subpart B.
Section 314.93 sets forth requirements
for submitting a suitability petition to
request a change from a listed drug in
accordance with § 10.20 (21 CFR 10.20)
and § 10.30. The burden hours for
§ 314.93 are approved under OMB
control number 0910–0191
(Administrative Practices and
Procedures; Formal Evidentiary Public
Hearing) and are not included in
table 1.
Section 314.94(a) through (d) require
that an ANDA contain the following
information: Application form; table of
contents; basis for ANDA submission;
conditions of use; active ingredients;
route of administration, dosage form,
and strength; bioequivalence; labeling;
chemistry, manufacturing, and controls;
samples; and patent certification.
Section 314.95 requires that any
notice of certification of invalidity or
non-infringement of a patent to each
patent owner and the NDA holder be
sent by ANDA applicants.
Section 314.96 sets forth requirements
for amendments to an unapproved
ANDA.
Section 314.97 sets forth requirements
for submitting supplements to an
approved ANDA for certain changes to
the application. Approval of burden
hours for information collections for
§§ 314.95 through 314.97 are covered
under OMB control number 0910–0786.
Section 314.98(a) sets forth
postmarketing adverse drug experience
reporting and recordkeeping
requirements for ANDAs. The burden
hours for § 314.98(a) are approved under
OMB control numbers 0910–0230 and
0910–0291 and are not included in table
1 of this document.
Section 314.98(b) requires other
postmarketing reports for ANDAs: Field
alert reports (Form FDA 3331a), annual
reports (Form FDA 2252), and
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advertisements and promotional
labeling (Form FDA 2253). (The
information collection burden estimate
for field alert reports is included in table
1 of this document under § 314.81(b)(1);
the estimate for annual reports is
included under § 314.81(b)(2); the
estimate for advertisements and
promotional labeling is included under
§ 314.81(b)(3)(i).)
Section 314.99(a) requires that
sponsors comply with certain reporting
requirements for withdrawing an
unapproved ANDA and for a change in
ownership of an ANDA.
Section 314.99(b) sets forth
requirements for sponsors who request
waivers from FDA for compliance with
§§ 314.92 through 314.99. (The
information collection burden estimate
for ANDA waiver requests is included
in table 1 of this document under the
estimates for each section that is in part
314, subpart C.)
Section 314.101(a) states that if FDA
refuses to file an application, the
applicant may request an informal
conference with FDA and request that
the application be filed over protest.
Section 314.102 covers
communications between FDA and
applicants, including requests for
meetings.
Section 314.103 covers specified
dispute resolution. To assist
respondents with certain aspects of this
requirement, we have issued draft
guidance entitled ‘‘Requests for
Reconsideration at the Division Level
Under GDUFA [the Generic Drug User
Fee Act]; Guidance for Industry.’’
Section 314.107(c) requires notice to
FDA by the first applicant to submit a
substantially complete ANDA
containing a certification that a relevant
patent is invalid, unenforceable, or will
not be infringed of the date of first
commercial marketing. The burden
estimate for § 314.107(c) is included in
table 1 under the estimates for
§ 314.50(a) through (g) and (i) through
(l).
Section 314.107(e) requires that an
applicant submit a copy of the entry of
the order or judgment to FDA within 10
working days of a final judgment. The
burden estimate for § 314.107(e)
applications is included in table 1 under
the estimates for § 314.50(a) through (g)
and (i) through (l) and is approved
under OMB control number 0910–0786.
Section 314.107(f) requires that
ANDA or section 505(b)(2) applicants
notify FDA immediately of the filing of
any legal action filed within 45 days of
receipt of the notice of certification. A
patent owner must also notify FDA of
the filing of any legal action for patent
infringement. If the patent owner or
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approved application holder who is an
exclusive patent licensee waives its
opportunity to file a legal action for
patent infringement within the 45-day
period, the patent owner or approved
application holder may submit to FDA
a waiver in the specified format. The
burden estimate for § 314.107(f) is
included in table 1 under the estimates
for § 314.50 (a) through (g) and (i)
through (l) and is approved under OMB
control number 0910–0786.
Section 314.110(b)(3) states that, after
receipt of an FDA complete response
letter, an applicant must either: (1)
Resubmit the application addressing all
the deficiencies identified in the
complete response letter; (2) withdraw
the application; or (3) request an
opportunity for a hearing on the
question of whether there are grounds
for denying approval of the application.
The burden hours for § 314.110(b)(3) are
included under parts 10 through 16 (21
CFR parts 10 through 16, OMB control
number 0910–0191) hearing regulations,
in accordance with § 314.201, and are
not included in table 1.
Section 314.122(a) requires that an
ANDA or a suitability petition that
relies on a listed drug that has been
voluntarily withdrawn from sale must
be accompanied by a petition seeking a
determination whether the drug was
withdrawn for safety or effectiveness
reasons. The burden hours for
§ 314.122(a) are approved under OMB
control number 0910–0191 and
therefore are not included in table 1.
Section 314.122(d) sets forth
requirements for relisting petitions for
unlisted discontinued products. The
burden hours for § 314.122(d) are
approved under OMB control number
0910–0191 and therefore are not
included in table 1.
Sections 314.125 and 314.127 state
that FDA may refuse to approve an NDA
or an ANDA and will provide the
applicant written notice of an
opportunity for a hearing under
§ 314.200 along with the reason for
refusal to approve the application,
including lack of a patent certification
or statement with respect to each listed
patent for an approved drug product
that is pharmaceutically equivalent to
the drug product for which the original
505(b)(2) application is submitted and
was approved before the original
505(b)(2) was submitted. The burden
hours for §§ 314.125 and 314.127 (refuse
to approve an ANDA) are included
under parts 10 through 16 hearing
regulations (in accordance with
§ 314.201) and approved under OMB
control number 0910–0191, and
therefore are not included in table 1.
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58405
Section 314.126(c) sets forth
requirements for a petition to waive
criteria for adequate and well-controlled
studies. The burden hours for
§ 314.126(c) are approved under OMB
control number 0910–0191 and
therefore are not included in table 1.
Sections 314.150(a) and (b) and
314.151(a) and (b) set forth requirements
for the withdrawal of approval of an
NDA or ANDA and the applicant’s
opportunity for a hearing and
submission of comments. The burden
hours for § 314.151(a) and (b) are
included under parts 10 through 16
hearing regulations, in accordance with
§ 314.201, and approved under OMB
control number 0910–0191 and
therefore are not included in table 1.
Section 314.151(c) sets forth the
requirements for withdrawal of approval
of an ANDA and the applicant’s
opportunity to submit written objections
and participate in a limited oral hearing.
The burden hours for § 314.151(c) are
included under parts 10 through 16
hearing regulations, in accordance with
§ 314.201, approved under OMB control
number 0910–0191, and therefore are
not included in table 1.
Section 314.153(b) sets forth the
requirements for suspension of an
ANDA when the listed drug is
voluntarily withdrawn for safety and
effectiveness reasons, and the
applicant’s opportunity to present
comments and participate in a limited
oral hearing. The burden hours for
§ 314.152(b) are included under parts 10
through 16 hearing regulations, in
accordance with § 314.201, approved
under OMB control number 0910–0191,
and therefore are not included in
table 1.
Section 314.161(b) and (e) sets forth
the requirements for submitting a
petition to determine whether a listed
drug was voluntarily withdrawn from
sale for safety or effectiveness reasons.
The burden hours for § 314.161(b) and
(e) are approved under OMB control
number 0910–0191 and therefore are not
included in table 1.
Section 314.200(c), (d), and (e)
requires that applicants or others subject
to a notice of opportunity for a hearing
who wish to participate in a hearing file
a written notice of participation and
request for a hearing as well as the
studies, data, and so forth, relied on.
Other interested persons may also
submit comments on the notice. This
section also sets forth the content and
format requirements for the applicants’
submission in response to notice of
opportunity for hearing. The burden
hours for § 314.200(c), (d), and (e) are
included under parts 10 through 16
hearing regulations, in accordance with
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§ 314.201, are approved under OMB
control number 0910–0191, and
therefore are not included in table 1.
Section 314.200(f) states that
participants in a hearing may make a
motion to the presiding officer for the
inclusion of certain issues in the
hearing. The burden hours for
§ 314.200(f) are included under parts 10
through 16 hearing regulations, in
accordance with § 314.201, are
approved under OMB control number
0910–0191, and therefore are not
included in table 1.
Section 314.200(g) states that a person
who responds to a proposed order from
FDA denying a request for a hearing
provide sufficient data, information, and
analysis to demonstrate that there is a
genuine and substantial issue of fact,
which justifies a hearing. The burden
hours for § 314.200(g) are included
under parts 10 through 16 hearing
regulations, in accordance with
§ 314.201, are approved under OMB
control number 0910–0191, and
therefore are not included in table 1.
Section 314.420 states that an
applicant may submit to FDA a drug
master file in support of an application,
in accordance with certain content and
format requirements.
Section 314.430 states that data and
information in an application are
disclosable under certain conditions,
unless the applicant shows that
extraordinary circumstances exist. The
burden hours for § 314.430 are included
under parts 10 through 16 hearing
regulations, in accordance with
§ 314.201, are approved under OMB
control number 0910–0191, and
therefore are not included in table 1.
Section 314.530(c) and (e) states that
if FDA withdraws approval of a drug
approved under the accelerated
approval procedures, the applicant has
the opportunity to request a hearing and
submit data and information. The
burden hours for § 314.530(c) and (e) are
included under parts 10 through 16
hearing regulations, in accordance with
§ 314.201, are approved under OMB
control number 0910–0191, and
therefore are not included in table 1.
Section 314.530(f) requires that an
applicant first submit a petition for stay
of action before requesting an order
from a court for a stay of action pending
review. The burden hours for
§ 314.530(f) are approved under OMB
control number 0910–0191, and
therefore are not included in table 1.
Section 314.550 requires an applicant
with a new drug product being
considered for accelerated approval to
submit copies of all promotional
materials to FDA during the preapproval
and post-approval periods.
Section 314.610(b)(1) requires that
applicants include a plan or approach to
postmarketing study commitments in
applications for approval of new drugs
when human efficacy studies are not
ethical or feasible, and provide status
reports of postmarketing study
commitments. The burden estimate for
§ 314.610(b)(1) is included in table 1
under the estimates for §§ 314.50(a)
through (f), (k), and (l); and
314.81(b)(2)).
Section 314.610(b)(3) requires that
applicants propose labeling to be
provided to patient recipients in
applications for approval of new drugs
when human efficacy studies are not
ethical or feasible. The burden estimate
for § 314.610(b)(3) is included in table 1
under the estimates for § 314.50(e).
Section 314.630 requires that
applicants provide postmarketing safety
reporting for applications for approval
of new drugs when human efficacy
studies are not ethical or feasible. The
burden hours for § 314.630 are approved
under OMB control numbers 0910–0230
and 0910–0291, and therefore not
included in table 1.
Section 314.640 requires that
applicants provide promotional
materials for applications for approval
of new drugs when human efficacy
studies are not ethical or feasible. The
burden estimate for § 314.640 is
included in table 1 under the estimates
for § 314.81(b)(3)(i)).
In the Federal Register of May 26,
2017 (82 FR 24351), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received in response to the four
information collection topics solicited
in the notice. However, one comment
was received regarding NDA submission
criteria, and we have directed the
comment to the appropriate Agency
component for consideration.
Accordingly, we estimate the burden
for this collection of information as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
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21 CFR section/[FDA form No.]
314.50 (a)–(g), (i)–(l)—Content and format of a 505(b)(1)
or 505(b)(2) application.
314.52—Non-infringement of patents (NDAs) ....................
314.95—Non-infringement of patents (ANDAs) ..................
314.60—Amendments .........................................................
314.65—Withdrawal of unapproved applications ................
314.70 and 314.71—Supplements and submissions ..........
314.72—Change of ownership ............................................
314.81—Other postmarketing reports and 314.81(b)(1)
[3331 and 3331a] field alert reports.
314.81(b)(2) [2252]—Annual reports ...................................
314.81(b)(3)(i) [2253]—Promotional labeling ......................
314.94(a) and (d)—ANDA content ......................................
314.96(a)(1)—Amendments to unapproved ANDAs ...........
314.97—Supplements to ANDAs ........................................
314.99(a)—Responsibilities of ANDA Applicants ................
314.101(a)—ANDA filing .....................................................
314.103—Dispute resolution ...............................................
314.420—Drug Master Files ...............................................
314.550—Promotional material and subpart H applications
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Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
378
1.33
503
1,921 ..............
966,263
7
209
564
27
838
142
342
3
3
9.96
71.63
7.04
2.04
19.98
21
627
5,618
1,934
5,897
289
6,834
16 ...................
16 ...................
80 ...................
2 .....................
150 .................
2 .....................
8 .....................
336
10,032
449,440
3,868
884,550
578
54,672
913
529
180.5
514
343
265
1
5.07
81.66
3.75
26.66
17.57
7.04
1
4,632
43,198
676.5
13,647
6,027
1,867
1
185,280
86,396
324,720
1,091,760
482,160
3,734
0.50
75
500
29
2
2.06
7.76
150
1,028
225
40 ...................
2 .....................
480 .................
80 ...................
80 ...................
2 .....................
0.50 ................
(30 minutes) ...
5 .....................
61 ...................
120 .................
Fmt 4703
Sfmt 4703
E:\FR\FM\12DEN1.SGM
12DEN1
750
62,708
27,000
Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices
58407
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2—Continued
Number of
respondents
21 CFR section/[FDA form No.]
Total ..............................................................................
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
4,634,247.5
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 For most elements, ‘‘Total Hours’’ reflects estimated average burden as calculated by multiplying the number of respondents by the frequency of response and time necessary for the corresponding activity. In other instances, ‘‘Total Hours’’ is the average burden we attribute to all
respondents, where individual respondent and time-frequency values have been estimated. All figures have been rounded to the nearest whole
number.
We retain the currently approved
burden estimate for the information
collection associated with the
provisions identified above. At the same
time, we have added burden estimate
associated with § 314.103, although in
an effort to reduce burden, we have
issued associated guidance to assist
respondents with the relevant
information collection.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–26670 Filed 12–11–17; 8:45 am]
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 February 12,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 12, 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:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1030]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Allergen
Labeling and Reporting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) 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 information
collection requirements for declaring
major food allergens under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by February 12, 2018.
ethrower on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:03 Dec 11, 2017
Jkt 244001
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.
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
• 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–
2014–N–1030 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Allergen Labeling and Reporting.’’
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/
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58403-58407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0523]
Agency Information Collection Activities: Submission for Office
of Management and Budget Review; Comment Request; Applications for Food
and Drug Administration Approval To Market a New Drug
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
11, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0001.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Application for FDA Approval To Market a New Drug
OMB Control Number 0910-0001--Extension
Under section 505(a) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(a)), a new drug may not be commercially
marketed in the United States, imported, or exported from the United
States, unless an approval of an application filed with FDA under
section 505(b) or (j) of the FD&C Act is effective with respect to such
drug. The Agency has codified regulations regarding applications for
FDA approval to market a new drug under 21 CFR part 314. This
collection of information supports the regulatory requirements found in
those regulations. The collection of information is necessary for FDA
to make a scientific and technical determination whether the product is
safe and effective for use, and is summarized as follows:
Section 314.50(a) requires that an application form (Form FDA 356h)
be submitted that includes information about the applicant, the
submission, and a checklist of enclosures.
Section 314.50(b) requires that an index be submitted with the
archival copy of the application and that it reference certain sections
of the application.
Section 314.50(c) requires that a summary of the application be
submitted that presents a good general synopsis of all the technical
sections and other information in the application.
Section 314.50(d) requires that the new drug application (NDA)
contain the following technical sections about the new drug: Chemistry,
manufacturing,
[[Page 58404]]
and controls; nonclinical pharmacology and toxicology; human
pharmacokinetics and bioavailability; microbiology; clinical data;
statistical; and pediatric use sections.
Section 314.50(e) requires the applicant to submit samples of the
drug if requested by FDA. In addition, the archival copy of the
application must include copies of the label and all labeling for the
drug.
Section 314.50(f) requires that case report forms and tabulations
be submitted with the archival copy.
Section 314.50(h) requires that patent information, as described
under Sec. [thinsp]314.53, be submitted with the application. However,
burden hours for Sec. [thinsp]314.50(h) are approved under OMB control
numbers 0910-0513 (Patent Certification Forms FDA 3542 and FDA 3542a)
and 0910-0786 (Abbreviated New Drug Applications (ANDAs) and 505(b)(2)
Applications), and are therefore not included among the estimates found
in table 1.
Section 314.50(i) requires that patent certification information be
submitted in section 505(b)(2) applications for patents claiming the
drug substance, drug product, or method of use. Sections
314.50(i)(1)(i)(C) and 314.54(i) and (j) require that patent
certification information be submitted for each patent listed in the
``Approved Drug Products with Therapeutic Equivalence Evaluations''
(the Orange Book) for a drug product approved in an NDA that is
pharmaceutically equivalent to the proposed drug product in the
original 505(b)(2) application and was submitted and was approved
before the original 505(b)(2) application was submitted. Burden for
these provisions is included under OMB control number 0910-0786.
Section 314.50(j) requires that applicants who request a period of
marketing exclusivity submit certain information with the application.
Section 314.50(k) requires that the application contain a financial
certification or disclosure statement or both.
Section 314.50(l) requires that an archival, review, and field copy
of the application be submitted, including the content of labeling and
all labeling and labels.
Section 314.52 requires that any notice of certification of
invalidity, unenforceability, or non-infringement of a patent to each
patent owner and the NDA holder be sent by a section 505(b)(2)
applicant that relies on a listed drug. A 505(b)(2) applicant is
required to amend the application at the time notice is provided to
include a statement certifying that the required notice has been
provided. A 505(b)(2) applicant also is required to amend the
application to document receipt of the required notice. Burden hours
for these provisions are included in OMB control number 0910-0786.
Section 314.53 sets forth the patent information requirements for
applicants who submit applications or amendments to the application
filed under section 505(b)(2) of the FD&C Act or supplements to the
approved 505(b)(2) application. Burden hours for these collections are
approved in OMB control number 0910-0786.
Section 314.54 sets forth the content requirements for applications
filed under section 505(b)(2) of the FD&C Act. The burden estimate for
505(b)(2) applications is included in table 1 under the estimates for
Sec. 314.50(a) through (g) and (i) through (l).
Section 314.55 sets forth the assessment requirements for each
application. The burden estimate for 505(b)(2) applications is included
in table 1 under the estimates for Sec. 314.50(a) through (g) and (i)
through (l).
Section 314.60 sets forth reporting requirements and patent
certification requirements for sponsors who amend an unapproved
505(b)(2) application. Burden hours for the Sec. 314.60(f) collections
are approved under OMB control number 0910-0786.
Section 314.65 states that the sponsor must notify FDA when
withdrawing an unapproved application.
Sections 314.70 and 314.71 require that supplements be submitted to
FDA for certain changes to an approved application.
Section 314.72 requires sponsors to report to FDA any transfer of
ownership of an application.
Section 314.80(c)(1) and (2) set forth requirements for expedited
adverse drug experience postmarketing reports and followup reports, as
well as for periodic adverse drug experience postmarketing reports
(Form FDA 3500A).
Section 314.80(i) establishes recordkeeping requirements for
reports of postmarketing adverse drug experiences. The burden hours for
Sec. 314.80(i) are approved under OMB control numbers 0910-0230
(Adverse Drug Experience Reporting) and 0910-0291 (MedWatch: FDA's
Medical Reporting Program), and therefore burden estimates are not
included in table 1.
Section 314.81(b)(1) requires that NDA and ANDA field alert reports
be submitted to FDA (Forms FDA 3331 and Form FDA 3331a).
Section 314.81(b)(2) requires that annual reports be submitted to
FDA (Form FDA 2252).
Section 314.81(b)(3)(i) requires that drug advertisements and
promotional labeling be submitted to FDA (Form FDA 2253).
Section 314.81(b)(3)(iii) sets forth reporting requirements for
sponsors who withdraw an approved drug product from sale. The burden
hours for Sec. 314.81(b)(3)(iii) are approved under OMB control number
0910-0045 (Registration of Producers of Drugs and Listing of Drugs in
Commercial Distribution), and therefore are not included in table 1.
Section 314.90 sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec. 314.50 through 314.81.
The information collection burden estimate for NDA waiver requests is
included in table 1 under the estimates for each section that is in
part 314, subpart B.
Section 314.93 sets forth requirements for submitting a suitability
petition to request a change from a listed drug in accordance with
Sec. 10.20 (21 CFR 10.20) and Sec. 10.30. The burden hours for Sec.
314.93 are approved under OMB control number 0910-0191 (Administrative
Practices and Procedures; Formal Evidentiary Public Hearing) and are
not included in table 1.
Section 314.94(a) through (d) require that an ANDA contain the
following information: Application form; table of contents; basis for
ANDA submission; conditions of use; active ingredients; route of
administration, dosage form, and strength; bioequivalence; labeling;
chemistry, manufacturing, and controls; samples; and patent
certification.
Section 314.95 requires that any notice of certification of
invalidity or non-infringement of a patent to each patent owner and the
NDA holder be sent by ANDA applicants.
Section 314.96 sets forth requirements for amendments to an
unapproved ANDA.
Section 314.97 sets forth requirements for submitting supplements
to an approved ANDA for certain changes to the application. Approval of
burden hours for information collections for Sec. Sec. 314.95 through
314.97 are covered under OMB control number 0910-0786.
Section 314.98(a) sets forth postmarketing adverse drug experience
reporting and recordkeeping requirements for ANDAs. The burden hours
for Sec. 314.98(a) are approved under OMB control numbers 0910-0230
and 0910-0291 and are not included in table 1 of this document.
Section 314.98(b) requires other postmarketing reports for ANDAs:
Field alert reports (Form FDA 3331a), annual reports (Form FDA 2252),
and
[[Page 58405]]
advertisements and promotional labeling (Form FDA 2253). (The
information collection burden estimate for field alert reports is
included in table 1 of this document under Sec. 314.81(b)(1); the
estimate for annual reports is included under Sec. 314.81(b)(2); the
estimate for advertisements and promotional labeling is included under
Sec. 314.81(b)(3)(i).)
Section 314.99(a) requires that sponsors comply with certain
reporting requirements for withdrawing an unapproved ANDA and for a
change in ownership of an ANDA.
Section 314.99(b) sets forth requirements for sponsors who request
waivers from FDA for compliance with Sec. Sec. 314.92 through 314.99.
(The information collection burden estimate for ANDA waiver requests is
included in table 1 of this document under the estimates for each
section that is in part 314, subpart C.)
Section 314.101(a) states that if FDA refuses to file an
application, the applicant may request an informal conference with FDA
and request that the application be filed over protest.
Section 314.102 covers communications between FDA and applicants,
including requests for meetings.
Section 314.103 covers specified dispute resolution. To assist
respondents with certain aspects of this requirement, we have issued
draft guidance entitled ``Requests for Reconsideration at the Division
Level Under GDUFA [the Generic Drug User Fee Act]; Guidance for
Industry.''
Section 314.107(c) requires notice to FDA by the first applicant to
submit a substantially complete ANDA containing a certification that a
relevant patent is invalid, unenforceable, or will not be infringed of
the date of first commercial marketing. The burden estimate for Sec.
314.107(c) is included in table 1 under the estimates for Sec.
314.50(a) through (g) and (i) through (l).
Section 314.107(e) requires that an applicant submit a copy of the
entry of the order or judgment to FDA within 10 working days of a final
judgment. The burden estimate for Sec. 314.107(e) applications is
included in table 1 under the estimates for Sec. 314.50(a) through (g)
and (i) through (l) and is approved under OMB control number 0910-0786.
Section 314.107(f) requires that ANDA or section 505(b)(2)
applicants notify FDA immediately of the filing of any legal action
filed within 45 days of receipt of the notice of certification. A
patent owner must also notify FDA of the filing of any legal action for
patent infringement. If the patent owner or approved application holder
who is an exclusive patent licensee waives its opportunity to file a
legal action for patent infringement within the 45-day period, the
patent owner or approved application holder may submit to FDA a waiver
in the specified format. The burden estimate for Sec. 314.107(f) is
included in table 1 under the estimates for Sec. 314.50 (a) through
(g) and (i) through (l) and is approved under OMB control number 0910-
0786.
Section 314.110(b)(3) states that, after receipt of an FDA complete
response letter, an applicant must either: (1) Resubmit the application
addressing all the deficiencies identified in the complete response
letter; (2) withdraw the application; or (3) request an opportunity for
a hearing on the question of whether there are grounds for denying
approval of the application. The burden hours for Sec. 314.110(b)(3)
are included under parts 10 through 16 (21 CFR parts 10 through 16, OMB
control number 0910-0191) hearing regulations, in accordance with Sec.
314.201, and are not included in table 1.
Section 314.122(a) requires that an ANDA or a suitability petition
that relies on a listed drug that has been voluntarily withdrawn from
sale must be accompanied by a petition seeking a determination whether
the drug was withdrawn for safety or effectiveness reasons. The burden
hours for Sec. 314.122(a) are approved under OMB control number 0910-
0191 and therefore are not included in table 1.
Section 314.122(d) sets forth requirements for relisting petitions
for unlisted discontinued products. The burden hours for Sec.
314.122(d) are approved under OMB control number 0910-0191 and
therefore are not included in table 1.
Sections 314.125 and 314.127 state that FDA may refuse to approve
an NDA or an ANDA and will provide the applicant written notice of an
opportunity for a hearing under Sec. 314.200 along with the reason for
refusal to approve the application, including lack of a patent
certification or statement with respect to each listed patent for an
approved drug product that is pharmaceutically equivalent to the drug
product for which the original 505(b)(2) application is submitted and
was approved before the original 505(b)(2) was submitted. The burden
hours for Sec. Sec. 314.125 and 314.127 (refuse to approve an ANDA)
are included under parts 10 through 16 hearing regulations (in
accordance with Sec. 314.201) and approved under OMB control number
0910-0191, and therefore are not included in table 1.
Section 314.126(c) sets forth requirements for a petition to waive
criteria for adequate and well-controlled studies. The burden hours for
Sec. 314.126(c) are approved under OMB control number 0910-0191 and
therefore are not included in table 1.
Sections 314.150(a) and (b) and 314.151(a) and (b) set forth
requirements for the withdrawal of approval of an NDA or ANDA and the
applicant's opportunity for a hearing and submission of comments. The
burden hours for Sec. 314.151(a) and (b) are included under parts 10
through 16 hearing regulations, in accordance with Sec. 314.201, and
approved under OMB control number 0910-0191 and therefore are not
included in table 1.
Section 314.151(c) sets forth the requirements for withdrawal of
approval of an ANDA and the applicant's opportunity to submit written
objections and participate in a limited oral hearing. The burden hours
for Sec. 314.151(c) are included under parts 10 through 16 hearing
regulations, in accordance with Sec. 314.201, approved under OMB
control number 0910-0191, and therefore are not included in table 1.
Section 314.153(b) sets forth the requirements for suspension of an
ANDA when the listed drug is voluntarily withdrawn for safety and
effectiveness reasons, and the applicant's opportunity to present
comments and participate in a limited oral hearing. The burden hours
for Sec. 314.152(b) are included under parts 10 through 16 hearing
regulations, in accordance with Sec. 314.201, approved under OMB
control number 0910-0191, and therefore are not included in table 1.
Section 314.161(b) and (e) sets forth the requirements for
submitting a petition to determine whether a listed drug was
voluntarily withdrawn from sale for safety or effectiveness reasons.
The burden hours for Sec. 314.161(b) and (e) are approved under OMB
control number 0910-0191 and therefore are not included in table 1.
Section 314.200(c), (d), and (e) requires that applicants or others
subject to a notice of opportunity for a hearing who wish to
participate in a hearing file a written notice of participation and
request for a hearing as well as the studies, data, and so forth,
relied on. Other interested persons may also submit comments on the
notice. This section also sets forth the content and format
requirements for the applicants' submission in response to notice of
opportunity for hearing. The burden hours for Sec. 314.200(c), (d),
and (e) are included under parts 10 through 16 hearing regulations, in
accordance with
[[Page 58406]]
Sec. 314.201, are approved under OMB control number 0910-0191, and
therefore are not included in table 1.
Section 314.200(f) states that participants in a hearing may make a
motion to the presiding officer for the inclusion of certain issues in
the hearing. The burden hours for Sec. 314.200(f) are included under
parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, are approved under OMB control number 0910-0191, and therefore
are not included in table 1.
Section 314.200(g) states that a person who responds to a proposed
order from FDA denying a request for a hearing provide sufficient data,
information, and analysis to demonstrate that there is a genuine and
substantial issue of fact, which justifies a hearing. The burden hours
for Sec. 314.200(g) are included under parts 10 through 16 hearing
regulations, in accordance with Sec. 314.201, are approved under OMB
control number 0910-0191, and therefore are not included in table 1.
Section 314.420 states that an applicant may submit to FDA a drug
master file in support of an application, in accordance with certain
content and format requirements.
Section 314.430 states that data and information in an application
are disclosable under certain conditions, unless the applicant shows
that extraordinary circumstances exist. The burden hours for Sec.
314.430 are included under parts 10 through 16 hearing regulations, in
accordance with Sec. 314.201, are approved under OMB control number
0910-0191, and therefore are not included in table 1.
Section 314.530(c) and (e) states that if FDA withdraws approval of
a drug approved under the accelerated approval procedures, the
applicant has the opportunity to request a hearing and submit data and
information. The burden hours for Sec. 314.530(c) and (e) are included
under parts 10 through 16 hearing regulations, in accordance with Sec.
314.201, are approved under OMB control number 0910-0191, and therefore
are not included in table 1.
Section 314.530(f) requires that an applicant first submit a
petition for stay of action before requesting an order from a court for
a stay of action pending review. The burden hours for Sec. 314.530(f)
are approved under OMB control number 0910-0191, and therefore are not
included in table 1.
Section 314.550 requires an applicant with a new drug product being
considered for accelerated approval to submit copies of all promotional
materials to FDA during the preapproval and post-approval periods.
Section 314.610(b)(1) requires that applicants include a plan or
approach to postmarketing study commitments in applications for
approval of new drugs when human efficacy studies are not ethical or
feasible, and provide status reports of postmarketing study
commitments. The burden estimate for Sec. 314.610(b)(1) is included in
table 1 under the estimates for Sec. Sec. 314.50(a) through (f), (k),
and (l); and 314.81(b)(2)).
Section 314.610(b)(3) requires that applicants propose labeling to
be provided to patient recipients in applications for approval of new
drugs when human efficacy studies are not ethical or feasible. The
burden estimate for Sec. 314.610(b)(3) is included in table 1 under
the estimates for Sec. 314.50(e).
Section 314.630 requires that applicants provide postmarketing
safety reporting for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. The burden hours for
Sec. 314.630 are approved under OMB control numbers 0910-0230 and
0910-0291, and therefore not included in table 1.
Section 314.640 requires that applicants provide promotional
materials for applications for approval of new drugs when human
efficacy studies are not ethical or feasible. The burden estimate for
Sec. [thinsp]314.640 is included in table 1 under the estimates for
Sec. 314.81(b)(3)(i)).
In the Federal Register of May 26, 2017 (82 FR 24351), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. No comments were received in response
to the four information collection topics solicited in the notice.
However, one comment was received regarding NDA submission criteria,
and we have directed the comment to the appropriate Agency component
for consideration.
Accordingly, we estimate the burden for this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden 1 2
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/[FDA form Number of responses per Total annual Average burden Total hours
No.] respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
314.50 (a)-(g), (i)-(l)-- 378 1.33 503 1,921............. 966,263
Content and format of a
505(b)(1) or 505(b)(2)
application.
314.52--Non-infringement of 7 3 21 16................ 336
patents (NDAs).
314.95--Non-infringement of 209 3 627 16................ 10,032
patents (ANDAs).
314.60--Amendments.......... 564 9.96 5,618 80................ 449,440
314.65--Withdrawal of 27 71.63 1,934 2................. 3,868
unapproved applications.
314.70 and 314.71-- 838 7.04 5,897 150............... 884,550
Supplements and submissions.
314.72--Change of ownership. 142 2.04 289 2................. 578
314.81--Other postmarketing 342 19.98 6,834 8................. 54,672
reports and 314.81(b)(1)
[3331 and 3331a] field
alert reports.
314.81(b)(2) [2252]--Annual 913 5.07 4,632 40................ 185,280
reports.
314.81(b)(3)(i) [2253]-- 529 81.66 43,198 2................. 86,396
Promotional labeling.
314.94(a) and (d)--ANDA 180.5 3.75 676.5 480............... 324,720
content.
314.96(a)(1)--Amendments to 514 26.66 13,647 80................ 1,091,760
unapproved ANDAs.
314.97--Supplements to ANDAs 343 17.57 6,027 80................ 482,160
314.99(a)--Responsibilities 265 7.04 1,867 2................. 3,734
of ANDA Applicants.
314.101(a)--ANDA filing..... 1 1 1 0.50.............. 0.50
(30 minutes)......
314.103--Dispute resolution. 75 2 150 5................. 750
314.420--Drug Master Files.. 500 2.06 1,028 61................ 62,708
314.550--Promotional 29 7.76 225 120............... 27,000
material and subpart H
applications.
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[[Page 58407]]
Total................... .............. .............. .............. .................. 4,634,247.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ For most elements, ``Total Hours'' reflects estimated average burden as calculated by multiplying the number
of respondents by the frequency of response and time necessary for the corresponding activity. In other
instances, ``Total Hours'' is the average burden we attribute to all respondents, where individual respondent
and time-frequency values have been estimated. All figures have been rounded to the nearest whole number.
We retain the currently approved burden estimate for the
information collection associated with the provisions identified above.
At the same time, we have added burden estimate associated with Sec.
314.103, although in an effort to reduce burden, we have issued
associated guidance to assist respondents with the relevant information
collection.
Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26670 Filed 12-11-17; 8:45 am]
BILLING CODE 4164-01-P