
[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Pages 24351-24356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0523]


Agency Information Collection Activities: Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the requirements governing applications for 
FDA approval to market a new drug.

DATES: Submit either electronic or written comments on the collection 
of information by June 26, 2017. Late, untimely filed comments will not 
be considered. Electronic comments must be submitted on or before July 
25, 2017. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time

[[Page 24352]]

at the end of July 25, 2017. 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: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2013-N-0523 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Applications for FDA Approval to 
Market a New Drug.'' Received comments, those filed in a timely manner 
(see DATES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
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.

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

[[Page 24353]]

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 NDA contain the following 
technical sections about the new drug: (1) Chemistry, manufacturing, 
and controls; (2) nonclinical pharmacology and toxicology; (3) human 
pharmacokinetics and bioavailability; (4) microbiology; (5) clinical 
data; (6) statistical; and (7) 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.  314.53, be submitted with the application. However, burden 
hours for Sec.  314.50(h) are approved under OMB control numbers 0910-
0513, Patent Certification Forms 3542 and 3542a and 0910-0786, 
Abbreviated New Drug Applications 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 its 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 its 
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.  [thinsp]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) sets 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 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.  [thinsp]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. Sec.  10.20 and 10.30. The burden hours for Sec.  [thinsp]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: (1) Application form; (2) table of contents; (3) 
basis for ANDA submission; (4) conditions of use; (5) active 
ingredients; (6) route of administration, dosage form, and strength; 
(7) bioequivalence; (8) labeling; (9) chemistry, manufacturing, and 
controls; (10) samples; and (11) 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

[[Page 24354]]

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.
    Section 314.98(b) requires other postmarketing reports for ANDAs: 
(1) Field alert reports (Form FDA 3331a); (2) annual reports (Form FDA 
2252); and (3) advertisements and promotional labeling (Form FDA 2253). 
(The information collection burden estimate for field alert reports is 
included in table 1 under Sec.  [thinsp]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 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 314.107(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 24355]]

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 the 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.  314.640 is included in table 1 under the estimates for Sec.  
314.81(b)(3)(i)).
    Accordingly, we estimate the burden for this collection of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 21 CFR Section/ [FDA Form No.]      Number of     responses per   Total  annual    burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
314.50(a)-(g), (i)-(l) [356h]--              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 unapproved              27           71.63            1934               2           3,868
 applications...................
314.70 and 314.71--Supplements               838            7.04           5,897             150         884,550
 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            4632              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 content.           180.5            3.75           676.5             480         324,720
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            6027              80         482,160
314.99(a)--Responsibilities of               265            7.04            1867               2           3,734
 ANDA Applicants................
314.101(a)--ANDA filing.........               1               1               1              .5              .5
                                                                                    (30 minutes)
314.420--Drug Master Files......             500            2.06           1,028              61          62,708
314.550--Promotional material                 29            7.76             225             120          27,000
 and subpart H applications.....
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............     4,633,497.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 24356]]

    Dated: May 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10818 Filed 5-25-17; 8:45 am]
BILLING CODE 4164-01-P


