[Federal Register Volume 73, Number 76 (Friday, April 18, 2008)]
[Notices]
[Pages 21139-21142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8459]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0321] (formerly Docket No. 2007N-0485)


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.

-----------------------------------------------------------------------

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 May 19, 
2008.

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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0111 and 
Application for Food and Drug Administration Approval to Market a New 
Drug. Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

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 Food and Drug Administration 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 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 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 on sponsors 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; and 
statistical section.
    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 an archival, review, and field copy 
of the application be submitted.
    Section 314.52 requires that any notice of certification of 
invalidity or noninfringement 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 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), 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 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. 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.)

[[Page 21140]]

    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). Form FDA 2253 
has been revised by FDA as follows: On line 8, ``Please check one or 
both'' has been revised to read ``Please check only one.'' In the 
instruction for line 8, the sentence ``Consumer and professional pieces 
should be submitted separately'' has been added.
    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.)
    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 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 any notice of certification of 
invalidity or noninfringement 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 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 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.
    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(a)(3) and (a)(4) states that, after receipt of an 
FDA approvable 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(a)(3) 
and (a)(4) are included under parts 10 through 16 (21 CFR part 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(a)(5) states that, after receipt of an approvable 
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 314.110(b) states that, after receipt of an approvable 
letter, an ANDA 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) 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 314.120(a)(3) states that, after receipt of a not 
approvable 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.  314.120(a)(3) 
are included under parts 10 through 16 hearing regulations, in 
accordance with Sec.  314.201, and are not included in the hour burden 
estimates in table 1 of this document.)
    Section 314.120(a)(5) states that, after receipt of a not 
approvable 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 0910-0183 and 
are not included in the burden estimates in table 1 of this document.)

[[Page 21141]]

    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 burden estimates in table 1 of this document.)
    Section 314.152(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 is 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 is 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 is included under parts 10 through 16 hearing regulations, in 
accordance with Sec.  314.201, and is 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 314.610(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), and (k) 
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 January 4, 2008 (73 FR 865), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
  21 CFR Section          No. of         No. of Responses       Total Annual        Hours Per
   [Form Number]       Respondents        Per Respondent         Responses          Response        Total Hours
----------------------------------------------------------------------------------------------------------------
314.50 (a), (b),                   85                  1.41                120          1,917            230,040
 (c), (d), (e),
 (f), and (k)
----------------------------------------------------------------------------------------------------------------

[[Page 21142]]

 
314.50(i) and                      96                  9.61                923              2              1,846
 314.94(a)(12)
----------------------------------------------------------------------------------------------------------------
314.50(j)                          71                  4.02                286              2                572
----------------------------------------------------------------------------------------------------------------
314.52 and 314.95                  71                  3.66                260             16              4,160
----------------------------------------------------------------------------------------------------------------
314.60                            305                 15.05              4,590             80            367,200
----------------------------------------------------------------------------------------------------------------
314.65                             13                  1.08                 14              2                 28
----------------------------------------------------------------------------------------------------------------
314.70 and 314.71                 281                  9.30              2,613            150            391,950
----------------------------------------------------------------------------------------------------------------
314.72                             69                  3.40                235              2                470
----------------------------------------------------------------------------------------------------------------
314.81(b)(1)                      114                  2.68                306              8              2,448
 [3331]
----------------------------------------------------------------------------------------------------------------
314.81(b)(2)                      724                 11.15              8,073             40            322,920
 [2252]
----------------------------------------------------------------------------------------------------------------
314.81(b)(3)(i)                   390                 61.39             23,942              2             47,884
 [2253]
----------------------------------------------------------------------------------------------------------------
314.94(a)(1)-(11)                 110                  7.21                793            480            380,640
 and (d)
----------------------------------------------------------------------------------------------------------------
314.96                            300                 28                 8,400             80            672,000
----------------------------------------------------------------------------------------------------------------
314.97                            215                 20.66              4,442             80            355,360
----------------------------------------------------------------------------------------------------------------
314.99(a)                          40                  2.02                 81              2                162
----------------------------------------------------------------------------------------------------------------
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(a)(5)                      45                  1.15                 52               .50              26
----------------------------------------------------------------------------------------------------------------
314.120(a)(5)                      10                  1.20                 12               .50               6
----------------------------------------------------------------------------------------------------------------
314.420                           487                  1.98                964             61             58,804
----------------------------------------------------------------------------------------------------------------
Total                                                                                                2,836,795.5
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8459 Filed 4-17-08; 8:45 am]
BILLING CODE 4160-01-S