[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]


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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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
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
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                                                 Number of
  21 CFR section/[FDA form       Number of     responses per   Total annual     Average  burden     Total hours
            No.]                respondents     respondent       responses       per  response
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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
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\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