[Federal Register Volume 75, Number 242 (Friday, December 17, 2010)]
[Notices]
[Pages 79001-79005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 requirements governing 
applications for FDA approval to market a new drug.

DATES: Submit either electronic or written comments on the collection 
of information by February 15, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
P150-400B, Rockville, MD 20850, 301-796-3792, 
<a href="/cdn-cgi/l/email-protection#4b0e2722312a292e3f2365092e39292a2024380b2d2f2a65232338652c243d"><span class="__cf_email__" data-cfemail="1e5b7277647f7c7b6a76305c7b6c7c7f75716d5e787a7f3076766d30797168">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal

[[Page 79002]]

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 505(j) of the FD&C Act is effective with respect to 
such a 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 information collection approval request is for all information 
requirements imposed by the regulations under part 314 (21 CFR 314) on 
sponsors 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 the applicant submit an application 
form (Form FDA 356h) that includes introductory information about the 
drug as well as a checklist of enclosures.
    Section 314.50(b) requires that the applicant submit an index with 
the archival copy of the application and that it reference certain 
sections of the application.
    Section 314.50(c) requires that the applicant submit a summary of 
the application 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 that the applicant 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 the applicant submit case report 
forms and tabulations with the archival copy.
    Section 314.50(h) requires that the applicant submit patent 
information, as described under Sec.  314.53, 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 the applicant submit patent 
certification information 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(l) requires that the applicant submit an archival, 
review, and field copy of the application.
    Section 314.52 requires that a section 505(b)(2) applicant that 
relies on a listed drug send any notice of certification of invalidity 
or noninfringement of a patent to each patent owner and the NDA holder 
. At the time notice is provided, a 505(b)(2) applicant is required to 
amend its application to include a statement certifying that the 
required notice has been provided. A section 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 section 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), and (k)).
    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 applicants submit 
supplements to FDA for certain changes to an approved application.
    Section 314.72 requires that sponsors 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 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 applicants submit field alert 
reports to FDA (Form FDA 3331).
    Section 314.81(b)(2) requires that applicants submit annual reports 
to FDA (Form FDA 2252).
    Section 314.81(b)(3)(i) requires that applicants submit drug 
advertisements and promotional labeling 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 estimates for Sec. Sec.  
314.50, 314.60, 314.70, and 314.71.)

[[Page 79003]]

    Section 314.93 sets forth requirements for submitting a suitability 
petition in accordance with 21 CFR 10.20 and 10.30. (The burden hours 
for Sec.  314.93 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 314.94(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 ANDA applicants send any notice of 
certification of invalidity or noninfringement of a patent to each 
patent owner and the NDA holder.
    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 changes that require FDA approval.
    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 estimates for Sec.  
314.94(a) and (d) and Sec. Sec.  314.96 and 314.97.)
    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 that the first applicant who submits a 
substantially complete ANDA containing a certification that a relevant 
patent is invalid, unenforceable, or will not be infringed submit 
notice to FDA of the date of first commercial marketing of its drug 
product.
    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.
    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.
    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 314.110(c) states that, after receipt of a complete 
response letter, an applicant may notify FDA that it agrees to an 
extension of the review period so that it can determine whether to 
respond further.
    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 OMB control 
number 0910-0183 and are not included in the burden estimates in table 
1 of this document.)
    Section 314.151(a) and (b) sets 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 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 and data on which they 
relied. Other interested persons may also submit comments on the 
notice. The 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 79004]]

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 OMB control number 0910-0194 and are 
not included in the burden estimates in table 1 of this document.)
    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 that applicants 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), and (k) 
and 314.81(b)(2)).
    Section 314.610(b)(3) requires that in applications for approval of 
new drugs when human efficacy studies are not ethical or feasible 
applicants propose labeling to provide to patient recipients. (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.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
  21 CFR Section; [Form Number]       No. of       frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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314.50 (a), (b), (c), (d), (e),               92            1.36             126           1,917         241,542
 (f), and (k)...................
314.50(i) and 314.94(a)(12).....              96            9.61             923               2           1,846
314.50(j).......................              71            4.02             286               2             572
314.52 and 314.95...............              71            3.66             260              16           4,160
314.60..........................             349           21.67           7,564              80         605,120
314.65..........................              10            1.20              12               2              24
314.70 and 314.71...............             620            4.91           3,050             150         457,500
314.72..........................             104            2.98             310               2             620
314.81(b)(1) [3331].............             147            2.57             378               8           3,024
314.81(b)(2) [2252].............             656           13.84           9,084              40         363,360
314.81(b)(3)(i) [2253]..........             490           61.48          30,130               2          60,260
314.94(a)(1)-(11) and (d).......             110            7.83             862             480         413,760
314.96..........................             292           35.82          10,461              80         836,880
314.97..........................             197           26.23           5,169              80         413,520
314.99(a).......................              53            2.30             122               2             244
314.101(a)......................               1            1                  1             .50             .50
314.107(c)--....................              56            4.1              230             .50             115
314.107(e)--....................              25            3.92              98             .50              49
314.107(f)--....................              56            4.1              230             .50             115
314.110(c)......................              11            1.36              15             .50             7.5
314.420.........................             524            1.98           1,038              61          63,318
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    Total.......................  ..............  ..............  ..............  ..............       3,466,037
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.



[[Page 79005]]

    Dated: December 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-31693 Filed 12-16-10; 8:45 am]
BILLING CODE 4160-01-P


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