[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Notices]
[Pages 29229-29233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14050]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0304]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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 reinstatement 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 comments on the collection of information by July
27, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
[[Page 29230]]
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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
(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 reinstatement 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)--Reinstatement
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.
The following sections in part 314 set forth the specific format
and content requirements for NDA's.
Section 314.50(a) requires that an application form (Form FDA 356h)
must be submitted that includes basic introductory information about
the drug as well as a checklist of enclosures. (Section 314.50(a) is
already approved by OMB under 0910-0338 and is not included in the hour
burden estimates in Table 1 of this document.)
Section 314.50(b) requires that an index must be submitted with the
archival copy of the application and that it must reference certain
sections of the application.
Section 314.50(c) requires that a summary of the application must
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 that the applicant must 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
must be submitted with the archival copy.
Section 314.50(h) requires that patent information as described
under Sec. 314.53 must be submitted with the application. (Section
314.50(h) is already approved by OMB under 0910-0305 and is not
included in the hour burden estimates in Table 1 of this document.)
Section 314.50(i) requires that a patent certification information
must be submitted in 505(b)(2) applications for patents claiming the
drug, drug product, method of use, or method of manufacturing. (Section
314.50(i) is already approved by OMB under 0910-0305 and is not
included in the hour burden estimates in Table 1 of this document.)
Section 314.50(j) requires that applicants that request a period of
marketing exclusivity must submit certain information with the
application. (Section 314.50(j) is already approved by OMB under 0910-
0305 and is not included in the hour burden estimates in Table 1 of
this document.)
Section 314.50(k) requires that an archival, review, and field copy
of the application must be submitted.
Section 314.52 requires that notice of certification of invalidity
or noninfringement of a patent to patent holders and NDA holders must
be sent by 505(b)(2) applicants and must follow certain content and
notification procedures. (Section 314.52 is already approved by OMB
under 0910-0305 and is not included in the hour burden estimates in
Table 1 of this document.)
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 must 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). (Section 314.80(c)(1) and (c)(2) is already
approved by OMB under 0910-0230 and 0910-0291 and is not included in
the hour burden estimates in Table 1 of this document.)
Section 314.80(c)(1)(iii) and (i) establishes recordkeeping
requirements for reports of postmarketing adverse drug experiences.
(Section 314.80(c)(1)(iii) and (i) is already approved by OMB under
0910-0230 and 0910-0291 and is not included in the hour burden
estimates in Table 1 of this document.)
[[Page 29231]]
Section 314.81(b)(1) requires that field alert reports must be
submitted to FDA (Form FDA 3331).
Section 314.81(b)(2) requires that annual reports must be submitted
to FDA (Form FDA 2252).
Section 314.81(b)(3)(i) requires that drug advertisements and
promotional labeling must be submitted to FDA (Form FDA 2253). (Section
314.81(b)(3)(i) is already approved by OMB in ``Transmittal of
Advertisements and Promotional Labeling for Drugs and Biologics for
Human Use,'' which published in the Federal Register of October 24,
1997 (62 FR 55408), and is not included in the hour burden estimates in
Table 1 of this document.)
Section 314.81(b)(3)(iii) sets forth reporting requirements for
sponsors who withdraw an approved drug product from sale. (Section
314.81(b)(3)(iii) is already approved by OMB under 0910-0045 and is 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. (Section 314.93 is
already approved by OMB under 0910-0183 and is not included in the hour
burden estimates in Table 1 of this document.)
The following sections in part 314 set forth requirements when
submitting an abbreviated new drug application (ANDA).
Section 314.94(a) and (d) requires that an ANDA must contain the
following and 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; and patent
certification.
Section 314.95 requires that notice of certification of invalidity
or noninfringement of a patent to patent holders and NDA holders must
be sent by ANDA applicants. (Section 314.95 is already approved by OMB
under 0910-0305 and is not included in the hour burden estimates in
Table 1 of this document.)
Section 314.96 sets forth requirements for amendments to an
unapproved application.
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. (Section 314.98(a) is already
approved by OMB under 0910-0230 and 0910-0291 and is not included in
the hour burden estimates in Table 1 of this document.)
Section 314.98(c) requires other postmarketing reports: 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 advertisements and promotional labeling is included under
Sec. 314.81(b)(3)(i).)
Section 314.99(a) requires that sponsors must 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) requires 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 505(b)(2)
application holders of any legal action concerning patent infringement.
(Section 314.107(c)(4) is already approved by OMB under 0910-0305 and
is not included in the hour burden estimates in Table 1 of this
document.)
Section 314.107(e)(2)(iv) requires that an applicant must submit a
copy of the entry of the order or judgement to FDA within 10 working
days of a final judgement. (Section 314.107(e)(2)(iv) is already
approved by OMB under 0910-0305 and is not included in the hour burden
estimates in Table 1 of this document.)
Section 314.107(f) requires that an ANDA or 505(b)(2) applicants
must 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 314.107(f) is
already approved by OMB under 0910-0305 and is not included in the hour
burden estimates in Table 1 of this document.)
Section 314.110(a)(3) and (a)(4) requires 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. (Section 314.110(a)(3) and (a)(4) is
included under the parts 10 through 16 (21 CFR part 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 314.110(a)(5) requires 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) requires 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. (Section 314.110(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 314.120(a)(3) requires 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. (Section 314.120(a)(3) 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 314.120(a)(5) requires 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) states 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. (Section
314.122(a) is already approved by OMB under 0910-0183 and is not
included in the hour burden estimates in Table 1 of this document.)
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Section 314.122(d) sets forth requirements for relisting petitions
for unlisted discontinued products. (Section 314.122(d) is already
approved by OMB under 0910-0183 and is 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. (Section 314.126(c)
is already approved by OMB under 0910-0183 and is 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 and approval of an ANDA and the applicant's opportunity
for a hearing and submission of comments. (Section 314.151(a) and (b)
is included under the parts 10 through 16 hearing regulations, in
accordance with Sec. 314.201, and it is 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. (Section
314.151(c) 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 314.152(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. (Section 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 and petition to determine whether a listed drug was
voluntarily withdrawn from sale for safety or effectiveness reasons.
(Section 314.161(b) and (e) is already approved by OMB under 0910-0183
and is 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 must 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. (Section 314.200(c), (d), and (e) 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 314.200(f) requires that participants in a hearing may make
a motion to the presiding officer for the inclusion of certain issues
in the hearing. (Section 314.200(f) 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 314.200(g) requires that a person may respond to a proposed
order from FDA denying a request for a hearing by providing sufficient
data, information, and analysis to demonstrate that there is a genuine
and substantial issue of fact which justifies a hearing. (Section
314.200(g) 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 314.420 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. (Section 314.430 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) requires 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. (Section 314.530(c) and (e) 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(f) requires that an applicant must first submit a
petition for stay of action before requesting an order from a court for
a stay of action pending review. (Section 314.530(f) is already
approved by OMB under 0910-0194 and is not included in the hour burden
estimates in Table 1 of this document.)
Section 314.550 requires that applicants must submit all
promotional materials to FDA for consideration during the preapproval
review period. (Section 314.550 is already approved by OMB in
``Transmittal of Advertisements and Promotional Labeling for Drugs and
Biologics for Human Use,'' which published in the Federal Register (62
FR 55408), and is not included in the hour burden estimates in Table 1
of this document.)
Based on information provided by the pharmaceutical industry for
the number of ``hours per response,'' and based on submissions
collected and data tabulated by FDA for the ``number of respondents,''
the ``number of responses per respondent,'' and the number of ``total
annual responses,'' FDA estimates the burden of this collection of
information as follows:
Table 1.--Estimated Annual Reporting Burden1
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No. of
21 CFR Section/Form No. of Responses per Total Annual Hours per Total Hours
Respondents Respondents Responses Response
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314.50(b), (c), (d), (e),
(f), and (k) 83 1.49 124 1,600 198,400
314.54 4 1.25 5 300 1,500
314.60 144 16.89 2,432 80 194,560
314.65 18 1.28 23 2 46
314.70 and 314.71 418 5.33 2,229 300 668,700
314.72 59 2.17 128 2 256
314.81(b)(1) (FDA 3331) 140 5 700 48 33,600
314.81(b)(2) (FDA 2252) 269 9.06 2,438 40 97,520
314.94(a) and (d) 117 3.96 464 480 222,720
314.96 315 12.43 3,915 80 313,200
314.97 152 19.74 3,000 80 240,000
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314.98(c) (FDA 2252) 265 17.17 4,551 40 182,040
314.99(a) 46 13.04 600 2 1,200
314.110(a)(5) 55 1.13 62 8 496
314.120(a)(5) 26 1.12 29 8 232
314.420 450 1.11 500 8 4,000
Total Burden Hours 2,158,470
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14050 Filed 5-27-98; 8:45 am]
BILLING CODE 4160-01-F
