[Federal Register Volume 66, Number 103 (Tuesday, May 29, 2001)]
[Notices]
[Pages 29143-29147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13303]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0205]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Applications for FDA 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 written or electronic comments on the collection of
information by July 30, 2001.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
Submit written comments on the collection of information to the to the
Dockets Management Branch (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: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
[[Page 29144]]
(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: (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.
Applications for FDA Approval to Market a New Drug--21 CFR Part 314
(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 (j) of the act is effective with respect to such
drug. Section 505(b) and (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 part 314), who apply for approval of a NDA 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) of the act 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) of the act 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 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 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).
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
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 Secs. 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 Secs. 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 0910-0183 and are not
included in the hour burden estimates in table 1 of this document).
[[Page 29145]]
Section 314.94(a) and (d) requires that an abbreviated new drug
application (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 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 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 Secs. 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
Secs. 314.94(a) and (d), 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) of the act 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) of the
act 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 the parts 10 through 16 (21 CFR part 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 314.110(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
the 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 the 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 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 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) 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 the 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 the 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 the 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 0910-0183 and are not included in the
[[Page 29146]]
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
opportunity for hearing. (The burden hours for Sec. 314.200(c), (d),
and (e) are included under the 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
the 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 that justifies a hearing. (The burden hours
for Sec. 314.200(g) are included under the 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 21 CFR 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. 314.530 is included under the 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 the 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).
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 Total Annual
21 CFR Section; [Form Number] No. of Respondents per Respondent Responses Hours per Response Total Hours
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314.50(a), (b), (c), (d), (e), (f), (h), and (k) 71 1.55 110 1,666 183,260
314.50() and 314.94(a)(12) 97 3.4 331 2 662
314.50(j) 92 2.7 250 2 500
314.52 and 314.95 37 2 75 16 1,200
314.54 11 1 11 300 3,300
314.60 125 19.92 2,490 80 199,200
314.65 29 1.24 36 2 72
314.70 and 314.71 204 11.54 2,354 300 706,200
314.72 70 2.90 205 2 410
314.81(b)(1) [3331] 82 3.43 281 8 2,248
314.81(b)(2) [2252] 600 12.66 7,597 40 303,880
314.81(b)(3)() [2253] 196 2.42 475 2 950
314.94(a) and (d) 125 2.92 365 480 175,200
314.96 225 7.25 1,631 80 130,480
314.97 175 17.44 3,052 80 244,160
314.99(a) 45 8.88 400 2 800
314.101(a) 6 1 6 .50 3
314.107(c)(4), (e)(2)(v), and (f) 34 2 71 1 71
314.110(a)(5) 50 1.66 83 .50 41.5
314.120(a)(5) 22 1.04 23 .50 11.5
314.420 462 1.1 514 61 31,354
Total 1,984,003
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 29147]]
Dated: May 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13303 Filed 5-25-01; 8:45 am]
BILLING CODE 4160-01-S