Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567, 65334-65338 [2013-25961]
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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Total burden
hours
annualized
Hourly wage
rate
Total cost
annualized
2,544 ............................................................................................................................................
137
$150
$52,279,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The average to industry per hour for
this type of work is $150, resulting in
a cost of $20,550 per respondent. The
estimated submission cost of $20,550
multiplied by 2,544 submissions per
year equals $52,279,200, which is the
aggregated industry reporting cost
annualized.
FDA’s annual estimate of 2,544
submissions is based on experienced
trends over the past several years. FDA’s
administrative and technical staffs, who
are familiar with the requirements for
current pre-submissions, estimate that
an average of 137 hours is required to
prepare a pre-submission. However, we
recognize there is a variance in the
preparation submission because of the
vast and varying complexities of
medical devices.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25964 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0578]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 December
2, 2013.
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SUMMARY:
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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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0338. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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.
ADDRESSES:
General Licensing Provisions: Biologics
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension,
Postmarketing Studies Status Reports,
and Forms FDA 356h and 2567—(0910–
0338)—Extension
Under section 351 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 262), manufacturers of biological
products must submit a license
application for FDA review and
approval before marketing a biological
product in interstate commerce.
Licenses may be issued only upon
showing that the establishment and the
products for which a license is desired
meets standards prescribed in
regulations designed to ensure the
continued safety, purity, and potency of
such products. All such licenses are
issued, suspended, and revoked as
prescribed by regulations in part 601 (21
CFR part 601).
Section 130(a) of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new
provision (section 506B of the FD&C Act
(21 U.S.C. 356b)) requiring reports of
postmarketing studies for approved
human drugs and licensed biological
products. Section 506B of the FD&C Act
provides FDA with additional authority
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Sfmt 4703
to monitor the progress of postmarketing
studies that applicants have made a
commitment to conduct and requires
the Agency to make publicly available
information that pertains to the status of
these studies. Under section 506B(a) of
the FD&C Act, applicants that have
committed to conduct a postmarketing
study for an approved human drug or
licensed biological product must submit
to FDA a status report of the progress of
the study or the reasons for the failure
of the applicant to conduct the study.
This report must be submitted within 1
year after the U.S. approval of the
application and then annually until the
study is completed or terminated.
A summary of the collection of
information requirements follows:
Section 601.2(a) requires a
manufacturer of a biological product to
submit an application on forms
prescribed for such purposes with
accompanying data and information,
including certain labeling information,
to FDA for approval to market a product
in interstate commerce. The container
and package labeling requirements are
provided under §§ 610.60 through
610.65 (21 CFR 610.60 through 610.65).
The estimate for these regulations is
included in the estimate under
§ 601.2(a) in table 1 of this document.
Section 601.5(a) requires a
manufacturer to submit to FDA notice of
its intention to discontinue manufacture
of a product or all products. Section
601.6(a) requires the manufacturer to
notify selling agents and distributors
upon suspension of its license, and
provide FDA of such notification.
Section 601.12(a)(2) requires,
generally, that the holder of an
approved Biologics Licensing
Application (BLA) must assess the
effects of a manufacturing change before
distributing a biological product made
with the change. Section 601.12(a)(4)
requires, generally, that the applicant
must promptly revise all promotional
labeling and advertising to make it
consistent with any labeling changes
implemented. Section 601.12(a)(5)
requires the applicant to include a list
of all changes contained in the
supplement or annual report; for
supplements, this list must be provided
in the cover letter. The burden estimates
for § 601.12(a)(2) are included in the
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estimates for supplements (§§ 601.12(b)
and (c)) and annual reports
(§ 601.12(d)). The burden estimates for
§ 601.12(a)(4) are included in the
estimates under 601.12(f)(4) in table 1 of
this document.
Sections 601.12(b)(1), (b)(3), (c)(1),
(c)(3), (c)(5), (d)(1), and (d)(3) require
applicants to follow specific procedures
to submit information to FDA of any
changes in the product, production
process, quality controls, equipment,
facilities, or responsible personnel
established in an approved license
application. The appropriate procedure
depends on the potential for the change
to have a substantial, moderate, or
minimal adverse effect on the identity,
strength, quality, purity, or potency of
the products as they may relate to the
safety or effectiveness of the product.
Under § 601.12(b)(4), an applicant may
ask FDA to expedite its review of a
supplement for public health reasons or
if a delay in making the change
described in it would impose an
extraordinary hardship of the applicant.
The burden estimate for § 601.12(b)(4) is
minimal and included in the estimate
under § 601.12(b)(1) and (b)(3) in table
1 of this document.
Section 601.12(e) requires applicants
to submit a protocol, or change to a
protocol, as a supplement requiring
FDA approval before distributing the
product. Section 601.12(f)(1), (f)(2), and
(f)(3) requires applicants to follow
specific procedures to report certain
labeling changes to FDA. Section
601.12(f)(4) requires applicants to report
to FDA advertising and promotional
labeling and any changes.
Under § 601.14, the content of
labeling required in 21 CFR
201.100(d)(3) must be in electronic
format and in a form that FDA can
process, review, and archive. This
requirement is in addition to the
provisions of §§ 601.2(a) and 601.12(f).
The burden estimate for § 601.14 is
minimal and included in the estimate
under §§ 601.2(a) (BLAs) and
601.12(f)(1), (f)(2), and (f)(3) (labeling
supplements and annual reports) in
table 1 of this document.
Section 601.45 requires applicants of
biological products for serious or lifethreatening illnesses to submit to the
Agency for consideration, during the
pre-approval review period, copies of all
promotional materials, including
promotional labeling as well as
advertisements.
In addition to §§ 601.2 and 601.12,
there are other regulations in 21 CFR
parts 640, 660, and 680 that relate to
information to be submitted in a license
application or supplement for certain
blood or allergenic products as follows:
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§§ 640.6; 640.17; 640.21(c); 640.22(c);
640.25(c); 640.56(c); 640.64(c); 640.74(a)
and (b)(2); 660.51(a)(4); and
680.1(b)(2)(iii) and (d).
In table 1 of this document, the
burden associated with the information
collection requirements in the
applicable regulations is included in the
burden estimate for §§ 601.2 and/or
601.12. A regulation may be listed
under more than one subsection of
§ 601.12 due to the type of category
under which a change to an approved
application may be submitted.
There are also additional container
and/or package labeling requirements
for certain licensed biological products
including: § 640.74(b)(3) and (4) for
Source Plasma Liquid; § 640.84(a) and
(c) for Albumin; § 640.94(a) for Plasma
Protein Fraction; § 660.2(c) for Antibody
to Hepatitis B Surface Antigen;
§ 660.28(a), (b), and (c) for Blood
Grouping Reagent; § 660.35(a), (c
through g), and (i through m) for
Reagent Red Blood Cells; § 660.45 for
Hepatitis B Surface Antigen; and
§ 660.55(a) and (b) for Anti-Human
Globulin. The burden associated with
the additional labeling requirements for
submission of a license application for
these certain biological products is
minimal because the majority of the
burden is associated with the
requirements under §§ 610.60 through
610.65 or 21 CFR 809.10. Therefore, the
burden estimates for these regulations
are included in the estimate under
§§ 610.60 through 610.65 in table 1 of
this document. The burden estimates
associated with § 809.10 are approved
under OMB control number 0910–0485.
Section 601.25(b) requests interested
persons to submit, for review and
evaluation by an advisory review panel,
published and unpublished data and
information pertinent to a designated
category of biological products that have
been licensed prior to July 1, 1972.
Section 601.26(f) requires that licensees
submit to FDA a written statement
intended to show that studies adequate
and appropriate to resolve the questions
raised about a biological product have
been undertaken for a product if
designated as requiring further study
under the reclassification procedures.
Under § 601.25(b), FDA estimates no
further burden for this regulation, and
therefore this regulation is not included
in table 1 of this document. Under
section 601.26(f), FDA estimates no
burden for this regulation since there
are no products designated to require
further study and none are predicted in
the future. However, FDA is using an
estimate of 1 for calculation purposes.
Based on the possible reclassification of
a product, the labeling for the product
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65335
may need to be revised, or a
manufacturer, on its own initiative, may
deem it necessary for further study. As
a result, any changes to product labeling
would be reported under the
appropriate subsection of § 601.12.
Section 601.27(a) requires that
applications for new biological products
contain data that are adequate to assess
the safety and effectiveness of the
biological product for the claimed
indications in pediatric subpopulations,
and to support dosing and
administration information. Section
601.27(b) provides that an applicant
may request a deferred submission of
some or all assessments of safety and
effectiveness required under § 601.27(a)
until after licensing the product for use
in adults. Section 601.27(c) provides
that an applicant may request a full or
partial waiver of the requirements under
§ 601.27(a) with adequate justification.
The burden estimates for § 601.27(a) are
included in the burden estimate under
§ 601.2(a) in table 1 of this document
since these regulations deal with
information to be provided in an
application.
Section 601.28 requires sponsors of
licensed biological products to submit
the information in § 601.28(a), (b), and
(c) to the Center for Biologics Evaluation
and Research (CBER) or to the Center for
Drug Evaluation and Research (CDER)
each year, within 60 days of the
anniversary date of approval of the
license. Section 601.28(a) requires
sponsors to submit to FDA a brief
summary stating whether labeling
supplements for pediatric use have been
submitted and whether new studies in
the pediatric population to support
appropriate labeling for the pediatric
population have been initiated. Section
601.28(b) requires sponsors to submit to
FDA an analysis of available safety and
efficacy data in the pediatric population
and changes proposed in the labeling
based on this information. Section
601.28(c) requires sponsors to submit to
FDA a statement on the current status of
any postmarketing studies in the
pediatric population performed by, on
or behalf of, the applicant. If the
postmarketing studies were required or
agreed to, the status of these studies is
to be reported under § 601.70 rather
than under this section.
Sections 601.33 through 601.35 clarify
the information to be submitted in an
application to FDA to evaluate the
safety and effectiveness of
radiopharmaceuticals intended for in
vivo administration for diagnostic and
monitoring use. The burden estimates
for §§ 601.33 through 601.35 are
included in the burden estimate under
§ 601.2(a) in table 1 of this document
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since these regulations deal with
information to be provided in an
application.
Section 601.70(b) requires each
applicant of a licensed biological
product to submit annually a report to
FDA on the status of postmarketing
studies for each approved product
application. Each annual postmarketing
status report must be accompanied by a
completed transmittal Form FDA 2252
(Form FDA 2252 approved under OMB
control number 0910–0001). Under
§ 601.70(d), two copies of the annual
report shall be submitted to FDA.
Sections 601.91 through 601.94
concern biological products for which
human efficacy studies are not ethical or
feasible. Section 601.91(b)(2) requires,
in certain circumstances, such
postmarketing restrictions as are needed
to ensure the safe use of the biological
product. Section 601.91(b)(3) requires
applicants to prepare and provide
labeling with relevant information to
patients or potential patients for
biological products approved under part
601, subpart H, when human efficacy
studies are not ethical or feasible (or
based on evidence of effectiveness from
studies in animals). Section 601.93
provides that biological products
approved under subpart H are subject to
the postmarketing recordkeeping and
safety reporting applicable to all
approved biological products. Section
601.94 requires applicants under
subpart H to submit to the Agency for
consideration during preapproval
review period copies of all promotional
materials including promotional
labeling as well as advertisements.
Under § 601.91(b)(2) and § 601.93, any
potential postmarketing reports and/or
recordkeeping burdens would be
included under the adverse experience
reporting (AER) requirements under 21
CFR part 600 (OMB control number
0910–0308). Therefore, any burdens
associated with these requirements
would be reported under the AER
information collection requirements
(OMB control number 0910–0308). The
burden estimate for § 601.91(b)(3) is
included in the estimate under
§§ 610.60 through 610.65.
Section 610.9(a) (21 CFR 610.9(a))
requires the applicant to present certain
information, in the form of a license
application or supplement to the
application, for a modification of any
particular test method or manufacturing
process or the conditions which it is
conducted under the biologics
regulations. The burden estimate for
§ 610.9(a) is included in the estimate
under §§ 601.2(a) and 601.12(b) and (c)
in table 1 of this document.
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Section 610.11(g)(2) (21 CFR
610.11(g)(2)) provides that a
manufacturer of certain biological
products may request an exemption
from the general safety test (GST)
requirements contained in subpart H.
Under § 610.11(g)(2), FDA requires only
those manufacturers of biological
products requesting an exemption from
the GST to submit additional
information as part of a license
application or supplement to an
approved license application. Therefore,
the burden estimate for § 610.11(g)(2) is
included in the estimate under
§§ 601.2(a) and 601.12(b) in table 1 of
this document.
Under 21 CFR 610.15(d) (21 CFR
610.15(d)), the Director of CBER or the
Director of CDER may approve, as
appropriate, a manufacturer’s request
for exceptions or alternatives to the
regulation for constituent materials.
Manufacturers seeking approval of an
exception or alternative must submit a
request in writing with a brief statement
describing the basis for the request and
the supporting data.
Section 640.120 requires
establishments to submit a request for
an exception or alternative to any
requirement in the biologics regulations
regarding blood, blood components, or
blood products. For licensed
establishments, a request for an
exception or alternative must be
submitted in accordance with § 601.12.
The burden estimate for § 640.120 is
included in the estimate under
§ 601.12(b) in table 1 of this document.
Section 680.1(c) requires
manufacturers to update annually their
license file with the list of source
materials and the suppliers of the
materials. Section 680.1(b)(3)(iv)
requires manufacturers to notify FDA
when certain diseases are detected in
source materials.
Sections 600.15(b) and 610.53(d) (21
CFR 610.53(d)) require the submission
of a request for an exemption or
modification regarding the temperature
requirements during shipment and from
dating periods, respectively, for certain
biological products. Section 606.110(b)
(21 CFR 606.110(b)) requires the
submission of a request for approval to
perform plasmapheresis of donors who
do not meet certain donor requirements
for the collection of plasma containing
rare antibodies. Under §§ 600.15(b),
610.53(d), and 606.110(b), a request for
an exemption or modification to the
requirements would be submitted as a
supplement. Therefore, the burden
hours for any submissions under
§§ 600.15(b), 610.53(d), and 606.110(b)
are included in the estimates under
§ 601.12(b) in table 1 of this document.
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In July 1997, FDA revised Form FDA
356h ‘‘Application to Market a New
Drug, Biologic, or an Antibiotic Drug for
Human Use’’ to harmonize application
procedures between CBER and CDER.
The application form serves primarily as
a checklist for firms to gather and
submit certain information to FDA. As
such, the form, now entitled
‘‘Application to Market a New or
Abbreviated New Drug or Biologic for
Human Use’’ helps to ensure that the
application is complete and contains all
the necessary information, so that
delays due to lack of information may
be eliminated. In addition, the form
provides key information to FDA for
efficient handling and distribution to
the appropriate staff for review. The
estimated burden hours for
nonbiological product submissions to
CDER using Form FDA 356h are
approved under OMB control number
0910–0001 (an estimated 3,200
submissions × 24 hours = 76,800 hours).
Form FDA 2567 ‘‘Transmittal of
Labels and Circulars’’ may be used by
manufacturers of licensed biological
products to submit labeling (e.g.,
circulars, package labels, container
labels, etc.) and labeling changes for
FDA review and approval. For
advertisements and promotional
labeling, manufacturers of licensed
biological products may submit to CBER
either Form FDA 2567 or 2253. Form
FDA 2253 was previously used only by
drug manufacturers regulated by CDER.
In August 1998, FDA revised and
harmonized Form FDA 2253 so the form
may be used to transmit specimens of
promotional labeling and
advertisements for biological products
as well as for prescription drugs and
antibiotics. The revised, harmonized
form updates the information about the
types of promotional materials and the
codes that are used to clarify the type of
advertisement or labeling submitted,
clarifies the intended audience for the
advertisements or promotional labeling
(e.g., consumers, professionals, news
services), and helps ensure that the
submission is complete. Form FDA 2253
is approved under OMB control number
0910–0001.
Under tables 1 and 2 of this
document, the numbers of respondents
are based on the estimated annual
number of manufacturers that submitted
the required information to FDA or the
number of submissions FDA received in
fiscal year 2012. Based on information
obtained from FDA’s database systems,
there are an estimated 323 licensed
biologics manufacturers. The total
annual responses are based on the
estimated number of submissions (i.e.,
license applications, labeling and other
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supplements, protocols, advertising and
promotional labeling, notifications) for a
particular product received annually by
FDA. The hours per response are based
on information provided by industry
and past FDA experience with the
various submissions or notifications.
The hours per response include the time
estimated to prepare the various
submissions or notifications to FDA,
and, as applicable, the time required to
fill out the appropriate form and collate
the documentation. Additional
information regarding these estimates is
provided below as necessary.
Under §§ 601.2 and 601.12, the
estimated hours per response are based
on the average number of hours to
submit the various submissions. The
estimated average number of hours is
based on the range of hours to complete
a very basic application or supplement
and a complex application or
supplement.
Under § 601.6(a), the total annual
responses are based on FDA estimates
that establishments may notify an
average of 20 selling agents and
distributors of such suspension, and
provide FDA of such notification. The
number of respondents is based on the
estimated annual number of
suspensions of a biologic license.
Under §§ 601.12(f)(4) and 601.45,
manufacturers of biological products
may use either Form FDA 2567 or Form
FDA 2253 to submit advertising and
promotional labeling. Based on
information obtained from FDA’s
database system, there were an
estimated 10,578 submissions of
advertising and promotional labeling.
Under §§ 601.28 and 601.70(b), FDA
estimates that it takes an applicant
approximately 24 hours (8 hours per
study × 3 studies) annually to gather,
complete, and submit the appropriate
information for each postmarketing
status report (approximately two to four
studies per report) and the accompanied
transmittal Form FDA 2252. Included in
these 24 hours is the time necessary to
65337
prepare and submit two copies of the
annual progress report of postmarketing
studies to FDA under § 601.70(d).
Under 21 CFR 610.15(d), FDA has
received no submissions since the
implementation of the final rule in April
2011. Therefore, FDA is estimating one
respondent and one annual request to
account for a possible submission to
CBER or CDER of a request for an
exception or alternative for constituent
materials under § 610.15(d).
There were a total of 2,664
amendments to an unapproved
application or supplement and
resubmissions submitted using Form
FDA 356h.
In the Federal Register of June 12,
2013 (78 FR 35273), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR section
Form FDA No.
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
601.2(a) 2, 610.60 through 610.65 3 .....
601.5(a) ................................................
601.6(a) ................................................
601.12(a)(5) .........................................
601.12(b)(1)/(b)(3)/(e) 4 ........................
601.12(c)(1)/(c)(3) 5 ..............................
601.12(c)(5) ..........................................
601.12(d)(1)/(d)(3) 6/(f)(3) 8 ..................
601.12(f)(1) 7 ........................................
601.12(f)(2) 7 ........................................
601.12(f)(4)/601.45 9 ............................
601.26(f) ...............................................
601.27(b) ..............................................
601.27(c) ..............................................
601.70(b) and (d)/601.28 .....................
610.15(d) ..............................................
680.1(c) ................................................
680.1(b)(3)(iv) ......................................
Amendments/Resubmissions ...............
2567/356h
NA
NA
NA
2 356h
2 356h
2 356h
2 356h
2567
2567
2567/2253
NA
NA
NA
2252
NA
NA
NA
356h
25
8
1
791
174
117
18
241
67
72
102
1
4
6
56
1
9
1
207
1.8
1
1
16.51
4.01
4.60
1.61
3.08
2.48
1.78
103.71
1
1
1
1.91
1
1
1
12.87
45
8
1
13,057
698
538
29
742
166
128
10,578
1
4
6
107
1
9
1
2,664
860
* 0.33
* 0.33
1
80
50
50
24
40
20
10
1
24
8
24
1
2
2
20
Total ..............................................
........................
........................
........................
........................
..........................
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1 There
Total hours
38,700
2.64
0.33
13,057
55,840
26,900
1,450
17,808
6,640
2,560
105,780
1
96
48
2,568
1
18
2
53,280
324,752
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The reporting requirements under §§ 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a), 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a).
3 The reporting requirements under §§ 601.93(b)(3), 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and
(c), 660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.65.
4 The reporting requirements under §§ 601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17,
640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b).
5 The reporting requirements under §§ 601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under
§ 601.12(c).
6 The reporting requirement under § 601.12(a)(2) is included in the estimate under § 601.12(d).
7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2).
8 The reporting requirement under §§ 601.12(a)(4) and 601.14 is included in the estimate under § 601.12(f)(3).
9 The reporting requirement under § 601.94 is included in the estimate under § 601.45.
* 20 minutes.
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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
21 CFR Section
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
601.6(a) ................................................................................
1
20
20
*0.33
6.6
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* 20 minutes.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
in brackets in the heading of this
document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
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.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2013–25961 Filed 10–30–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0663]
Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and
Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans—(OMB Control
Number 0910–0672)—Extension
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 December
2, 2013.
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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0672. Also
include the FDA docket number found
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
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In the Federal Register of September
29, 2010 (75 FR 59935), FDA published
a document entitled ‘‘Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans.’’ The document
clarified the Agency’s expectations for
timely review, evaluation, and
submission of relevant and useful safety
information and implemented
internationally harmonized definitions
and reporting standards for IND safety
reports. The document also required
safety reporting for bioavailability and
bioequivalence studies. The document
was intended to improve the utility of
IND safety reports, expedite FDA’s
review of critical safety information,
better protect human subjects enrolled
in clinical trials, and harmonize safety
reporting requirements internationally.
The rulemaking included the
following information collection under
the PRA that was not already included
in 21 CFR 312.32 and approved under
OMB control number 0910–0014.
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Section 312.32(c)(1)(ii) and (c)(1)(iii)
requires reporting to FDA, in an IND
safety report, of potential serious risks
from clinical trials within 15 calendar
days for findings from epidemiological
studies, pooled analyses of multiple
studies, or other clinical studies that
suggest a significant risk in humans
exposed to the drug.
Section 312.32(c)(1)(iii) specifies the
requirements for reporting to FDA in an
IND safety report potential serious risks
from clinical trials within 15 calendar
days for findings from in vitro testing
that suggest a significant risk to humans.
FDA estimates that approximately 100
sponsors spend a total of approximately
12 hours per report to prepare and
submit approximately 600 reports
annually.
Section 312.32(c)(1)(iv) requires
reporting to FDA in an IND safety report
within 15 calendar days of any
clinically important increase in the rate
of occurrence of serious suspected
adverse reactions over that listed in the
protocol or investigator brochure. FDA
estimates that approximately 10
sponsors spend a total of approximately
12 hours per report to prepare and
submit approximately 10 reports
annually.
The rulemaking also included new
information collection under the PRA
by requiring safety reporting for
bioavailability and bioequivalence
studies (21 CFR 320.31(d)). FDA
estimates that approximately 10
sponsors spend a total of approximately
14 hours per report to prepare and
submit approximately 200 reports
annually.
In the Federal Register of June 12,
2013 (78 FR 35283), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\31OCN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65334-65338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25961]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0578]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Licensing
Provisions: Biologics License Application, Changes to an Approved
Application, Labeling, Revocation and Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h and 2567
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
December 2, 2013.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0338.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@fda.hhs.gov.
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.
General Licensing Provisions: Biologics License Application, Changes to
an Approved Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Forms FDA 356h and 2567--
(0910-0338)--Extension
Under section 351 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 262), manufacturers of biological products must submit a
license application for FDA review and approval before marketing a
biological product in interstate commerce. Licenses may be issued only
upon showing that the establishment and the products for which a
license is desired meets standards prescribed in regulations designed
to ensure the continued safety, purity, and potency of such products.
All such licenses are issued, suspended, and revoked as prescribed by
regulations in part 601 (21 CFR part 601).
Section 130(a) of the Food and Drug Administration Modernization
Act of 1997 (Pub. L. 105-115) amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by adding a new provision (section 506B of
the FD&C Act (21 U.S.C. 356b)) requiring reports of postmarketing
studies for approved human drugs and licensed biological products.
Section 506B of the FD&C Act provides FDA with additional authority to
monitor the progress of postmarketing studies that applicants have made
a commitment to conduct and requires the Agency to make publicly
available information that pertains to the status of these studies.
Under section 506B(a) of the FD&C Act, applicants that have committed
to conduct a postmarketing study for an approved human drug or licensed
biological product must submit to FDA a status report of the progress
of the study or the reasons for the failure of the applicant to conduct
the study. This report must be submitted within 1 year after the U.S.
approval of the application and then annually until the study is
completed or terminated.
A summary of the collection of information requirements follows:
Section 601.2(a) requires a manufacturer of a biological product to
submit an application on forms prescribed for such purposes with
accompanying data and information, including certain labeling
information, to FDA for approval to market a product in interstate
commerce. The container and package labeling requirements are provided
under Sec. Sec. 610.60 through 610.65 (21 CFR 610.60 through 610.65).
The estimate for these regulations is included in the estimate under
Sec. 601.2(a) in table 1 of this document.
Section 601.5(a) requires a manufacturer to submit to FDA notice of
its intention to discontinue manufacture of a product or all products.
Section 601.6(a) requires the manufacturer to notify selling agents and
distributors upon suspension of its license, and provide FDA of such
notification.
Section 601.12(a)(2) requires, generally, that the holder of an
approved Biologics Licensing Application (BLA) must assess the effects
of a manufacturing change before distributing a biological product made
with the change. Section 601.12(a)(4) requires, generally, that the
applicant must promptly revise all promotional labeling and advertising
to make it consistent with any labeling changes implemented. Section
601.12(a)(5) requires the applicant to include a list of all changes
contained in the supplement or annual report; for supplements, this
list must be provided in the cover letter. The burden estimates for
Sec. 601.12(a)(2) are included in the
[[Page 65335]]
estimates for supplements (Sec. Sec. 601.12(b) and (c)) and annual
reports (Sec. 601.12(d)). The burden estimates for Sec. 601.12(a)(4)
are included in the estimates under 601.12(f)(4) in table 1 of this
document.
Sections 601.12(b)(1), (b)(3), (c)(1), (c)(3), (c)(5), (d)(1), and
(d)(3) require applicants to follow specific procedures to submit
information to FDA of any changes in the product, production process,
quality controls, equipment, facilities, or responsible personnel
established in an approved license application. The appropriate
procedure depends on the potential for the change to have a
substantial, moderate, or minimal adverse effect on the identity,
strength, quality, purity, or potency of the products as they may
relate to the safety or effectiveness of the product. Under Sec.
601.12(b)(4), an applicant may ask FDA to expedite its review of a
supplement for public health reasons or if a delay in making the change
described in it would impose an extraordinary hardship of the
applicant. The burden estimate for Sec. 601.12(b)(4) is minimal and
included in the estimate under Sec. 601.12(b)(1) and (b)(3) in table 1
of this document.
Section 601.12(e) requires applicants to submit a protocol, or
change to a protocol, as a supplement requiring FDA approval before
distributing the product. Section 601.12(f)(1), (f)(2), and (f)(3)
requires applicants to follow specific procedures to report certain
labeling changes to FDA. Section 601.12(f)(4) requires applicants to
report to FDA advertising and promotional labeling and any changes.
Under Sec. 601.14, the content of labeling required in 21 CFR
201.100(d)(3) must be in electronic format and in a form that FDA can
process, review, and archive. This requirement is in addition to the
provisions of Sec. Sec. 601.2(a) and 601.12(f). The burden estimate
for Sec. 601.14 is minimal and included in the estimate under
Sec. Sec. 601.2(a) (BLAs) and 601.12(f)(1), (f)(2), and (f)(3)
(labeling supplements and annual reports) in table 1 of this document.
Section 601.45 requires applicants of biological products for
serious or life-threatening illnesses to submit to the Agency for
consideration, during the pre-approval review period, copies of all
promotional materials, including promotional labeling as well as
advertisements.
In addition to Sec. Sec. 601.2 and 601.12, there are other
regulations in 21 CFR parts 640, 660, and 680 that relate to
information to be submitted in a license application or supplement for
certain blood or allergenic products as follows: Sec. Sec. 640.6;
640.17; 640.21(c); 640.22(c); 640.25(c); 640.56(c); 640.64(c);
640.74(a) and (b)(2); 660.51(a)(4); and 680.1(b)(2)(iii) and (d).
In table 1 of this document, the burden associated with the
information collection requirements in the applicable regulations is
included in the burden estimate for Sec. Sec. 601.2 and/or 601.12. A
regulation may be listed under more than one subsection of Sec. 601.12
due to the type of category under which a change to an approved
application may be submitted.
There are also additional container and/or package labeling
requirements for certain licensed biological products including: Sec.
640.74(b)(3) and (4) for Source Plasma Liquid; Sec. 640.84(a) and (c)
for Albumin; Sec. 640.94(a) for Plasma Protein Fraction; Sec.
660.2(c) for Antibody to Hepatitis B Surface Antigen; Sec. 660.28(a),
(b), and (c) for Blood Grouping Reagent; Sec. 660.35(a), (c through
g), and (i through m) for Reagent Red Blood Cells; Sec. 660.45 for
Hepatitis B Surface Antigen; and Sec. 660.55(a) and (b) for Anti-Human
Globulin. The burden associated with the additional labeling
requirements for submission of a license application for these certain
biological products is minimal because the majority of the burden is
associated with the requirements under Sec. Sec. 610.60 through 610.65
or 21 CFR 809.10. Therefore, the burden estimates for these regulations
are included in the estimate under Sec. Sec. 610.60 through 610.65 in
table 1 of this document. The burden estimates associated with Sec.
809.10 are approved under OMB control number 0910-0485.
Section 601.25(b) requests interested persons to submit, for review
and evaluation by an advisory review panel, published and unpublished
data and information pertinent to a designated category of biological
products that have been licensed prior to July 1, 1972. Section
601.26(f) requires that licensees submit to FDA a written statement
intended to show that studies adequate and appropriate to resolve the
questions raised about a biological product have been undertaken for a
product if designated as requiring further study under the
reclassification procedures. Under Sec. 601.25(b), FDA estimates no
further burden for this regulation, and therefore this regulation is
not included in table 1 of this document. Under section 601.26(f), FDA
estimates no burden for this regulation since there are no products
designated to require further study and none are predicted in the
future. However, FDA is using an estimate of 1 for calculation
purposes. Based on the possible reclassification of a product, the
labeling for the product may need to be revised, or a manufacturer, on
its own initiative, may deem it necessary for further study. As a
result, any changes to product labeling would be reported under the
appropriate subsection of Sec. 601.12.
Section 601.27(a) requires that applications for new biological
products contain data that are adequate to assess the safety and
effectiveness of the biological product for the claimed indications in
pediatric subpopulations, and to support dosing and administration
information. Section 601.27(b) provides that an applicant may request a
deferred submission of some or all assessments of safety and
effectiveness required under Sec. 601.27(a) until after licensing the
product for use in adults. Section 601.27(c) provides that an applicant
may request a full or partial waiver of the requirements under Sec.
601.27(a) with adequate justification. The burden estimates for Sec.
601.27(a) are included in the burden estimate under Sec. 601.2(a) in
table 1 of this document since these regulations deal with information
to be provided in an application.
Section 601.28 requires sponsors of licensed biological products to
submit the information in Sec. 601.28(a), (b), and (c) to the Center
for Biologics Evaluation and Research (CBER) or to the Center for Drug
Evaluation and Research (CDER) each year, within 60 days of the
anniversary date of approval of the license. Section 601.28(a) requires
sponsors to submit to FDA a brief summary stating whether labeling
supplements for pediatric use have been submitted and whether new
studies in the pediatric population to support appropriate labeling for
the pediatric population have been initiated. Section 601.28(b)
requires sponsors to submit to FDA an analysis of available safety and
efficacy data in the pediatric population and changes proposed in the
labeling based on this information. Section 601.28(c) requires sponsors
to submit to FDA a statement on the current status of any postmarketing
studies in the pediatric population performed by, on or behalf of, the
applicant. If the postmarketing studies were required or agreed to, the
status of these studies is to be reported under Sec. 601.70 rather
than under this section.
Sections 601.33 through 601.35 clarify the information to be
submitted in an application to FDA to evaluate the safety and
effectiveness of radiopharmaceuticals intended for in vivo
administration for diagnostic and monitoring use. The burden estimates
for Sec. Sec. 601.33 through 601.35 are included in the burden
estimate under Sec. 601.2(a) in table 1 of this document
[[Page 65336]]
since these regulations deal with information to be provided in an
application.
Section 601.70(b) requires each applicant of a licensed biological
product to submit annually a report to FDA on the status of
postmarketing studies for each approved product application. Each
annual postmarketing status report must be accompanied by a completed
transmittal Form FDA 2252 (Form FDA 2252 approved under OMB control
number 0910-0001). Under Sec. 601.70(d), two copies of the annual
report shall be submitted to FDA.
Sections 601.91 through 601.94 concern biological products for
which human efficacy studies are not ethical or feasible. Section
601.91(b)(2) requires, in certain circumstances, such postmarketing
restrictions as are needed to ensure the safe use of the biological
product. Section 601.91(b)(3) requires applicants to prepare and
provide labeling with relevant information to patients or potential
patients for biological products approved under part 601, subpart H,
when human efficacy studies are not ethical or feasible (or based on
evidence of effectiveness from studies in animals). Section 601.93
provides that biological products approved under subpart H are subject
to the postmarketing recordkeeping and safety reporting applicable to
all approved biological products. Section 601.94 requires applicants
under subpart H to submit to the Agency for consideration during
preapproval review period copies of all promotional materials including
promotional labeling as well as advertisements. Under Sec.
601.91(b)(2) and Sec. 601.93, any potential postmarketing reports and/
or recordkeeping burdens would be included under the adverse experience
reporting (AER) requirements under 21 CFR part 600 (OMB control number
0910-0308). Therefore, any burdens associated with these requirements
would be reported under the AER information collection requirements
(OMB control number 0910-0308). The burden estimate for Sec.
601.91(b)(3) is included in the estimate under Sec. Sec. 610.60
through 610.65.
Section 610.9(a) (21 CFR 610.9(a)) requires the applicant to
present certain information, in the form of a license application or
supplement to the application, for a modification of any particular
test method or manufacturing process or the conditions which it is
conducted under the biologics regulations. The burden estimate for
Sec. 610.9(a) is included in the estimate under Sec. Sec. 601.2(a)
and 601.12(b) and (c) in table 1 of this document.
Section 610.11(g)(2) (21 CFR 610.11(g)(2)) provides that a
manufacturer of certain biological products may request an exemption
from the general safety test (GST) requirements contained in subpart H.
Under Sec. 610.11(g)(2), FDA requires only those manufacturers of
biological products requesting an exemption from the GST to submit
additional information as part of a license application or supplement
to an approved license application. Therefore, the burden estimate for
Sec. 610.11(g)(2) is included in the estimate under Sec. Sec.
601.2(a) and 601.12(b) in table 1 of this document.
Under 21 CFR 610.15(d) (21 CFR 610.15(d)), the Director of CBER or
the Director of CDER may approve, as appropriate, a manufacturer's
request for exceptions or alternatives to the regulation for
constituent materials. Manufacturers seeking approval of an exception
or alternative must submit a request in writing with a brief statement
describing the basis for the request and the supporting data.
Section 640.120 requires establishments to submit a request for an
exception or alternative to any requirement in the biologics
regulations regarding blood, blood components, or blood products. For
licensed establishments, a request for an exception or alternative must
be submitted in accordance with Sec. 601.12. The burden estimate for
Sec. 640.120 is included in the estimate under Sec. 601.12(b) in
table 1 of this document.
Section 680.1(c) requires manufacturers to update annually their
license file with the list of source materials and the suppliers of the
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA
when certain diseases are detected in source materials.
Sections 600.15(b) and 610.53(d) (21 CFR 610.53(d)) require the
submission of a request for an exemption or modification regarding the
temperature requirements during shipment and from dating periods,
respectively, for certain biological products. Section 606.110(b) (21
CFR 606.110(b)) requires the submission of a request for approval to
perform plasmapheresis of donors who do not meet certain donor
requirements for the collection of plasma containing rare antibodies.
Under Sec. Sec. 600.15(b), 610.53(d), and 606.110(b), a request for an
exemption or modification to the requirements would be submitted as a
supplement. Therefore, the burden hours for any submissions under
Sec. Sec. 600.15(b), 610.53(d), and 606.110(b) are included in the
estimates under Sec. 601.12(b) in table 1 of this document.
In July 1997, FDA revised Form FDA 356h ``Application to Market a
New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize
application procedures between CBER and CDER. The application form
serves primarily as a checklist for firms to gather and submit certain
information to FDA. As such, the form, now entitled ``Application to
Market a New or Abbreviated New Drug or Biologic for Human Use'' helps
to ensure that the application is complete and contains all the
necessary information, so that delays due to lack of information may be
eliminated. In addition, the form provides key information to FDA for
efficient handling and distribution to the appropriate staff for
review. The estimated burden hours for nonbiological product
submissions to CDER using Form FDA 356h are approved under OMB control
number 0910-0001 (an estimated 3,200 submissions x 24 hours = 76,800
hours).
Form FDA 2567 ``Transmittal of Labels and Circulars'' may be used
by manufacturers of licensed biological products to submit labeling
(e.g., circulars, package labels, container labels, etc.) and labeling
changes for FDA review and approval. For advertisements and promotional
labeling, manufacturers of licensed biological products may submit to
CBER either Form FDA 2567 or 2253. Form FDA 2253 was previously used
only by drug manufacturers regulated by CDER. In August 1998, FDA
revised and harmonized Form FDA 2253 so the form may be used to
transmit specimens of promotional labeling and advertisements for
biological products as well as for prescription drugs and antibiotics.
The revised, harmonized form updates the information about the types of
promotional materials and the codes that are used to clarify the type
of advertisement or labeling submitted, clarifies the intended audience
for the advertisements or promotional labeling (e.g., consumers,
professionals, news services), and helps ensure that the submission is
complete. Form FDA 2253 is approved under OMB control number 0910-0001.
Under tables 1 and 2 of this document, the numbers of respondents
are based on the estimated annual number of manufacturers that
submitted the required information to FDA or the number of submissions
FDA received in fiscal year 2012. Based on information obtained from
FDA's database systems, there are an estimated 323 licensed biologics
manufacturers. The total annual responses are based on the estimated
number of submissions (i.e., license applications, labeling and other
[[Page 65337]]
supplements, protocols, advertising and promotional labeling,
notifications) for a particular product received annually by FDA. The
hours per response are based on information provided by industry and
past FDA experience with the various submissions or notifications. The
hours per response include the time estimated to prepare the various
submissions or notifications to FDA, and, as applicable, the time
required to fill out the appropriate form and collate the
documentation. Additional information regarding these estimates is
provided below as necessary.
Under Sec. Sec. 601.2 and 601.12, the estimated hours per response
are based on the average number of hours to submit the various
submissions. The estimated average number of hours is based on the
range of hours to complete a very basic application or supplement and a
complex application or supplement.
Under Sec. 601.6(a), the total annual responses are based on FDA
estimates that establishments may notify an average of 20 selling
agents and distributors of such suspension, and provide FDA of such
notification. The number of respondents is based on the estimated
annual number of suspensions of a biologic license.
Under Sec. Sec. 601.12(f)(4) and 601.45, manufacturers of
biological products may use either Form FDA 2567 or Form FDA 2253 to
submit advertising and promotional labeling. Based on information
obtained from FDA's database system, there were an estimated 10,578
submissions of advertising and promotional labeling.
Under Sec. Sec. 601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x 3 studies)
annually to gather, complete, and submit the appropriate information
for each postmarketing status report (approximately two to four studies
per report) and the accompanied transmittal Form FDA 2252. Included in
these 24 hours is the time necessary to prepare and submit two copies
of the annual progress report of postmarketing studies to FDA under
Sec. 601.70(d).
Under 21 CFR 610.15(d), FDA has received no submissions since the
implementation of the final rule in April 2011. Therefore, FDA is
estimating one respondent and one annual request to account for a
possible submission to CBER or CDER of a request for an exception or
alternative for constituent materials under Sec. 610.15(d).
There were a total of 2,664 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
In the Federal Register of June 12, 2013 (78 FR 35273), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a) \2\, 610.60 through 610.65 \3\.................. 2567/356h 25 1.8 45 860 38,700
601.5(a)................................................. NA 8 1 8 * 0.33 2.64
601.6(a)................................................. NA 1 1 1 * 0.33 0.33
601.12(a)(5)............................................. NA 791 16.51 13,057 1 13,057
601.12(b)(1)/(b)(3)/(e) \4\.............................. \2\ 356h 174 4.01 698 80 55,840
601.12(c)(1)/(c)(3) \5\.................................. \2\ 356h 117 4.60 538 50 26,900
601.12(c)(5)............................................. \2\ 356h 18 1.61 29 50 1,450
601.12(d)(1)/(d)(3) \6\/(f)(3) \8\....................... \2\ 356h 241 3.08 742 24 17,808
601.12(f)(1) \7\......................................... 2567 67 2.48 166 40 6,640
601.12(f)(2) \7\......................................... 2567 72 1.78 128 20 2,560
601.12(f)(4)/601.45 \9\.................................. 2567/2253 102 103.71 10,578 10 105,780
601.26(f)................................................ NA 1 1 1 1 1
601.27(b)................................................ NA 4 1 4 24 96
601.27(c)................................................ NA 6 1 6 8 48
601.70(b) and (d)/601.28................................. 2252 56 1.91 107 24 2,568
610.15(d)................................................ NA 1 1 1 1 1
680.1(c)................................................. NA 9 1 9 2 18
680.1(b)(3)(iv).......................................... NA 1 1 1 2 2
Amendments/Resubmissions................................. 356h 207 12.87 2,664 20 53,280
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Total................................................ .............. .............. ............. .............. .............. 324,752
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec. Sec. 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a), 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec. 601.2(a).
\3\ The reporting requirements under Sec. Sec. 601.93(b)(3), 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b),
and (c), 660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under Sec. Sec. 610.60 through 610.65.
\4\ The reporting requirements under Sec. Sec. 601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17,
640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec.
601.12(b).
\5\ The reporting requirements under Sec. Sec. 601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate
under Sec. 601.12(c).
\6\ The reporting requirement under Sec. 601.12(a)(2) is included in the estimate under Sec. 601.12(d).
\7\ The reporting requirement under Sec. 601.14 is included in the estimate under Sec. 601.12(f)(1) and (f)(2).
\8\ The reporting requirement under Sec. Sec. 601.12(a)(4) and 601.14 is included in the estimate under Sec. 601.12(f)(3).
\9\ The reporting requirement under Sec. 601.94 is included in the estimate under Sec. 601.45.
* 20 minutes.
[[Page 65338]]
Table 2--Estimated Annual Third Party Disclosure Burden \1\
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Number of
21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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601.6(a)........................................................... 1 20 20 *0.33 6.6
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 20 minutes.
Dated: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25961 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P
