[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Notices]
[Pages 55801-55804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0627]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Application 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 October 
17, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 505(j) of the act is effective with respect to such 
drug. Under the FD&C Act, it is the sponsor's responsibility to provide 
the information needed by FDA to make a scientific and technical 
determination whether the product is safe and effective for use.
    This approval request is for all information collection 
requirements imposed on applicants by the regulations under part 314 
(21 CFR part 314) who apply for approval of a new drug application 
(NDA) or abbreviated new drug application (ANDA) in order to market or 
to continue to market a drug.
    Section 314.50(a) requires that an application form (Form FDA 356h) 
be submitted that includes introductory information about the drug as 
well as 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 NDA contain the following 
technical sections about the new drug: Chemistry, manufacturing, 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.  314.53, be submitted with the application. (The burden 
hours for Sec.  314.50(h) are already approved by OMB under OMB control 
number 0910-0513 and are not included in the burden estimates in Table 
1 of this document.)
    Section 314.50(i) requires that patent certification information be 
submitted in section 505(b)(2) applications for patents claiming the 
drug, drug product, or method of use.
    Section 314.50(j) requires that applicants that 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 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.
    Section 314.54 sets forth the content requirements for applications 
filed under section 505(b)(2) of the FD&C Act. (The information 
collection burden estimate for 505(b)(2) applications is included in 
table 1 of this document under the estimates for Sec.  314.50 (a), (b), 
(c), (d), (e), (f), (g), (i), (j), (k) and (l)).
    Section 314.60 sets forth reporting requirements for sponsors who 
amend an unapproved application.
    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 (c)(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). (The burden hours for Sec.  314.80(c)(1) and 
(c)(2) are already approved by OMB under OMB control numbers 0910-0230 
and 0910-0291 and are not included in the burden estimates in table 1 
of this document.)
    Section 314.80(i) establishes recordkeeping requirements for 
reports of postmarketing adverse drug experiences. (The burden hours 
for

[[Page 55802]]

Sec.  314.80(i) are already approved by OMB under OMB control numbers 
0910-0230 and 0910-0291 and are not included in the burden estimates in 
table 1 of this document.)
    Section 314.81(b)(1) requires that field alert reports be submitted 
to FDA (Form FDA 3331).
    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 already approved by OMB under OMB 
control number 0910-0045 and are not included in the burden estimates 
in table 1 of this document.)
    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 of this document under the estimates for each 
section that is in subpart B of part 314.)
    Section 314.93 sets forth requirements for submitting a suitability 
petition in accordance with Sec.  10.20 (21 CFR 10.20) and Sec.  10.30. 
(The burden hours for Sec.  314.93 are already approved by OMB under 
0910-0183 and are not included in the burden estimates in table 1 of 
this document.)
    Section 314.94(a) and (d) requires 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; 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.
    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 already approved by OMB under OMB control 
numbers 0910-0230 and 0910-0291 and are not included in the burden 
estimates in table 1 of this document.)
    Section 314.98(c) requires other postmarketing reports for ANDAs: 
Field alert reports (Form FDA 3331), annual reports (Form FDA 2252), 
and 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 subpart C of part 314.)
    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 information collection 
burden estimate for Sec.  314.107(c) is included in table 1 of this 
document under the estimates for Sec.  314.50 (a), (b), (c), (d), (e), 
(f), (g), (i), (j), (k) and (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 information collection burden estimate for Sec.  
314.107(e) applications is included in table 1 of this document under 
the estimates for Sec.  314.50 (a), (b), (c), (d), (e), (f), (g), (i), 
(j), (k) and (l)).
    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 may 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 must submit to FDA a waiver 
in the specified format. (The information collection burden estimate 
for Sec.  314.107(f) is included in table 1 of this document under the 
estimates for Sec.  314.50 (a), (b), (c), (d), (e), (f), (g), (i), (j), 
(k) and (l)).
    Section 314.110(b)(3) states that, after receipt of an FDA complete 
response letter, an applicant may 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 and 16) hearing regulations, 
in accordance with Sec.  314.201, and are not included in the burden 
estimates in table 1 of this document.)
    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 already approved by OMB under OMB 
control number 0910-0183 and are not included in the burden estimates 
in table 1 of this document.)
    Section 314.122(d) sets forth requirements for relisting petitions 
for unlisted discontinued products. (The burden hours for Sec.  
314.122(d) are already approved by OMB under OMB control number 0910-
0183 and are not included in the burden estimates in table 1 of this 
document.)
    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 already approved by OMB under 0910-0183 and 
are not included in the burden estimates in table 1 of this document.)
    Section 314.151(a) and (b) set forth requirements for the 
withdrawal of approval of an 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 are not included in 
the burden estimates in table 1 of this document.)
    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, and are not included in 
the

[[Page 55803]]

burden estimates in table 1 of this document.)
    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, and are not included in 
the burden estimates in table 1 of this document.)
    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 already approved by 
OMB under OMB control number 0910-0183 and are not included in the 
burden estimates in table 1 of this document.)
    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 Sec.  314.201, and are not included in the burden 
estimates in table 1 of this document.)
    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, and are not included in the burden estimates in table 1 of 
this document.)
    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, and are not included in 
the burden estimates in table 1 of this document.)
    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, and are not included in the burden 
estimates in table 1 of this document.)
    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, and are not included in the burden estimates in 
table 1 of this document.)
    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 already approved by OMB under 0910-0194 and are not included in the 
burden estimates in table 1 of this document.)
    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 information collection burden estimate for Sec.  
314.610(b)(1) is included in table 1 of this document under the 
estimates for Sec. Sec.  314.50 (a), (b), (c), (d), (e), (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 
information collection burden estimate for Sec.  314.610(b)(3) is 
included in table 1 of this document 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 already approved by OMB under OMB control numbers 
0910-0230 and 0910-0291 and are not included in the burden estimates in 
table 1 of this document.)
    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 information 
collection burden estimate for Sec.  314.640 is included in table 1 of 
this document under the estimates for Sec.  314.81(b)(3)(i)).
    Respondents to this collection of information are all persons who 
submit an application or abbreviated application or an amendment or 
supplement to FDA under Part 314 to obtain approval of a new drug, and 
any person who owns an approved application or abbreviated application.
    In the Federal Register of March 24, 2014 (79 FR 16003), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment. The comment 
requested clarification of the duties, responsibilities, and potential 
liabilities of the person denoted as the ``Authorized U.S. Agent'' in 
field 39 of Form FDA 356h. The comment also requested that the 
formatting for field 39 be revised to clarify, ``What exactly it is 
that the Authorized U.S. Agent is attesting to by its signature.''
    FDA response: Neither the form nor the instructions are intended to 
capture the exact duties, responsibilities, and potential liabilities 
of the person identified in field 39. Rather, as the instructions 
indicate, field 39 is intended to capture a countersignature where one 
is required in accordance with 21 CFR 314.50(a)(5): If the person 
signing the form in Field 38 does not reside or have a place of 
business within the United States, the form must be countersigned in 
Field 39 by an attorney, agent, or other authorized official who 
resides or maintains a place of business within the United States.

[[Page 55804]]



                                   Table 1--Estimated Annual Reporting Burden
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                                                     Number of                        Average
 21 CFR Section; [FDA Form No.]      Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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314.50(a), (b), (c), (d), (e),               106            1.42             151        1,921         290,071
 (f), (g), (i), (j), (k) and (l)
 [356h].........................
314.52..........................               7            3                 21           16             336
314.95..........................             209            3                627           16          10,032
314.60..........................             277            8.73           2,419           80         193,520
314.65..........................              18            1.16              21            2              42
314.70 and 314.71...............             374            7.63           2,854          150         428,100
314.72..........................              66            2.20             145            2             290
314.81(b)(1) [3331].............             260           16.31           4,241            8          33,928
314.81(b)(2) [2252].............             930           11.28          10,495           40         419,800
314.81(b)(3)(i) [2253]..........             520           87.43          45,461            2          90,922
314.94(a) and (d)...............             251            4.73           1,186          480         569,280
314.96..........................             434           24.60          10,675           80         854,000
314.97..........................             306           18.34           5,611           80         448,880
314.99(a).......................             219            3.01             659            2           1,318
314.101(a)......................               1            1                  1           * .50             .50
314.420.........................             524            1.98           1,038           61          63,318
314.550.........................              20            7                140          120          16,800
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    Total.......................  ..............  ..............  ..............  ..............    3,420,637.50
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There are no capital costs or operating and maintenance costs associated with this collection of information.
* 30 minutes.


    Dated: September 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22088 Filed 9-16-14; 8:45 am]
BILLING CODE 4164-01-P