[Federal Register Volume 70, Number 19 (Monday, January 31, 2005)]
[Notices]
[Pages 4853-4857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0441]


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 March 
2, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

[[Page 4854]]


FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (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 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 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. Section 505(b) and 505(j) of the act requires a sponsor to submit 
to FDA a new drug application (NDA) containing, among other things, 
full reports of investigations that show whether or not the drug is 
safe and effective for use, a full list of articles used as components 
in the drug, a full description of manufacturing methods, samples of 
the drugs required, specimens of the labeling proposed to be used, and 
certain patent information as applicable. Under the act, it is the 
sponsor's responsibility to provide the information needed by FDA to 
make a scientific and technical determination that the product is safe 
and effective.
    This information collection approval request is for all information 
requirements imposed on sponsors by the regulations under part 314 (21 
CFR 314), who apply for approval of a new drug application 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.
    Section 314.50(i) requires that patent certification information be 
submitted in section 505(b)(2) applications for patents claiming the 
drug, drug product, method of use, or method of manufacturing.
    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 notice of certification of invalidity 
or noninfringement of a patent to patent holders and NDA holders be 
sent by section 505(b)(2) applicants.
    Section 314.54 sets forth the content requirements for applications 
filed under section 505(b)(2) of the act.
    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 hour 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 hour 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). This form has been revised as a result of the 
requirements in the final rule ``Postmarketing Studies for Approved 
Human Drug and Licensed Biological Products; Status Reports,'' 
published in the Federal Register of October 30, 2000 (65 FR 64607). 
The rule describes the types of postmarketing studies covered by the 
status reports, the information to be included in the reports, and the 
type of information that FDA would consider appropriate for public 
disclosure. The rule implemented section 130(a) of the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). The changes to the 
form include adding new spaces for the new status reports, reporting 
for biological products, and editorial changes.
    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 hour 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 hour 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 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 hour 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 notice of certification of invalidity 
or noninfringement of a patent to patent

[[Page 4855]]

holders and NDA holders 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 hour 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 hour 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 hour 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)(4) requires notice to FDA by ANDA or section 
505(b)(2) application holders of any legal action concerning patent 
infringement.
    Section 314.107(e)(2)(iv) 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 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. 
The patent owner or approved application holder who is an exclusive 
patent licensee must submit to FDA a waiver that waives the opportunity 
to file a legal action for patent infringement.
    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 hour 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 hour 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 hour 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 hour 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 hour 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 hour 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 hour 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) is included under parts 10 through 16 hearing 
regulations, in accordance with Sec.  314.201, and is not included in 
the hour 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 hour 
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

[[Page 4856]]

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 hour 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 hour 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 hour 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 hour 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 hour 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 
hour burden estimates in table 1 of this document.)
    In the Federal Register of October 8, 2004 (69 FR 60402), FDA 
announced an opportunity for public comment on these information 
collection estimates. No comments were submitted that pertained to the 
information collection estimates in the October 8, 2004, document.
    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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                                                                  No. of Responses per       Total Annual
     21 CFR Section; [FDA Form Number]        No. of Respondents       Respondent             Responses         Hours Per Response       Total Hours
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314.50 (a), (b), (c), (d), (e), (f), (h),                     72                  1.44                    104                 1,642              170,768
 and (k)
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314.50(i) and 314.94(a)(12)                                  194                  2.34                    454                     2                  908
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314.50(j)                                                     70                  3.71                    260                     2                  520
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314.52 and 314.95                                             24                  2.25                     54                    16                  864
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314.54                                                        16                     1                     16                   300                4,800
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314.60                                                       275                 19.06                  5,242                    80              419,320
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314.65                                                        10                     1                     10                     2                   20
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314.70 and 314.71                                            234                 10.99                  2,572                   150              385,800
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314.72                                                        61                  4.52                    276                     2                  552
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314.81(b)(1) [3331]                                          115                  3.88                    447                     8                3,576
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314.81(b)(2) [2252]                                          612                 12.47                  7,632                    40              305,280
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314.81(b)(3)(i) [2253]                                       332                 44.09                 14,638                     2               29,276
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314.94(a) and (d)                                            100                  4.59                    459                   480              220,320
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314.96                                                       275                 23.63                  6,500                    80              520,000
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314.97                                                       200                 16.75                  3,350                    80              268,000
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314.99(a)                                                     44                  2.02                     89                     2                  178
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314.101(a)                                                     2                     1                      2                   .50                    1
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[[Page 4857]]

 
314.107(c)(4), 314.107(e)(2)(iv), and                          3                     2                      6                     1                    6
 314.107(f)
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314.110(a)(5)                                                 41                  1.26                     52                   .50                   26
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314.120(a)(5)                                                 12                  1.16                     14                   .50                    7
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314.420                                                      403                  1.72                    694                    61               42,334
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Total                                                                                                                                          2,372,556
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: January 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1814 Filed 1-27-05; 12:53 pm]
BILLING CODE 4160-01-S