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, and Postmarketing Studies Status Reports, 75130-75134 [2016-26064]
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75130
Dated: October 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–26066 Filed 10–27–16; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2013–N–0578]
BILLING CODE 4164–01–C
mstockstill on DSK3G9T082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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, and Postmarketing
Studies Status Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
SUMMARY:
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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 November
28, 2016.
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.
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Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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 Form FDA 356h OMB Control
Number 0910–0338—Extension
Under Section 351 of the Public
Health Services 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 (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
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FOR FURTHER INFORMATION CONTACT:
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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.
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 License 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
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.
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.
Section 601.12(e) requires applicants
to submit a protocol, or change to a
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75131
protocol, as a supplement requiring
FDA approval before distributing the
product. Section 601.12(f)(1), (2), and
(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), (2), and (3) (labeling
supplements and annual reports) in
table 1.
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:
§§ 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, 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
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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. The
burden estimates associated with
§ 809.10 are approved under OMB
control number 0910–0485.
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 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
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§ 601.2(a) in table 1 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
postmarking 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) 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.
Under § 610.15(d), the Director of
CBER or the Director of CDER may
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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 licensed
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;
therefore, the burden estimate for
§ 640.120 is included in the estimate
under § 601.12(b) in table 1.
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.
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
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estimated burden hours for
nonbiological product submissions to
CDER using FDA Form 356h are
approved under OMB control number
0910–0001 (an estimated 3,200
submissions ×24 hours = 76,800 hours).
For advertisements and promotional
labeling (e. g., circulars, package labels,
container labels, etc.) and labeling
changes, manufacturers of licensed
biological products may submit to CBER
or CDER Form FDA 2253. In August of
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
can also be submitted electronically.
Form FDA 2253 is approved under OMB
control number 0910–0001.
Respondents to this collection of
information are manufacturers of
biological products. Under tables 1 and
2, 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 (FY) 2015. Based on
information obtained from FDA’s
database systems, there are an estimated
391 licensed biologics manufacturers.
The total annual responses are based on
the estimated number of submissions
(i.e., license applications, labeling and
other 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 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 section 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. In
table 1, FDA is estimating 1 in case a
suspension occurs.
Under §§ 601.12(f)(4) and 601.45,
manufacturers of biological products
may use Form FDA 2253 to submit
advertising and promotional labeling
(which can include multiple pieces).
75133
Based on information obtained from
FDA’s database system, there were an
estimated 11,676 submissions using
Form FDA 2253 of advertising and
promotional labeling from 114
respondents.
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
prepare and submit two copies of the
annual progress report of postmarketing
studies to FDA under § 601.70(d). For
FY 2015, there were 139 reports from 82
respondents.
Under § 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 2,777
amendments to an unapproved
application or supplement and
resubmissions submitted using Form
FDA 356h.
In the Federal Register of July 11,
2016 (81 FR 44868), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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21 CFR Section
Form FDA No.
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 ..........................
601.27(b) ............................................
601.27(c) ............................................
601.70(b) and (d)/601.28 ...................
610.15(d) ............................................
680.1(c) ..............................................
680.1(b)(3)(iv) ....................................
Amendments/Resubmissions ............
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Number of
respondents
356h
NA
NA
NA
2 356h
2 356h
2 356h
2 356h
2253
2253
2253
NA
NA
2252
NA
NA
NA
356h
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Frm 00108
Number of
responses per
respondent
28
12
1
537
164
120
7
246
72
60
114
20
12
82
1
9
1
125
Fmt 4703
1.36
0.75
1
24.41
3.66
4.78
1.14
3.34
1.93
1.82
102.42
16.50
1.08
1.70
1
1
1
22.22
Sfmt 4703
Total annual
responses
Average burden
per response
38
9
1
13,106
600
574
8
822
139
109
11,676
330
13
139
1
9
1
2,777
E:\FR\FM\28OCN1.SGM
860 .......................
0.33 (20 minutes)
0.33 (20 minutes)
1 ...........................
80 .........................
50 .........................
50 .........................
24 .........................
40 .........................
20 .........................
10 .........................
24 .........................
8 ...........................
24 .........................
1 ...........................
2 ...........................
2 ...........................
20 .........................
28OCN1
Total hours 10
32,680
3
1
13,106
48,000
28,700
400
19,728
5,560
2,180
116,670
7,920
104
3,336
1
18
2
55,540
75134
Federal Register / Vol. 81, No. 209 / Friday, October 28, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Form FDA No.
21 CFR Section
Total ............................................
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
........................
........................
........................
........................
..............................
Total hours 10
333,949
1 There
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), 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), 640.74(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), 610.53(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.
10 The numbers in this column have been rounded to the nearest whole number.
Under table 2, the estimated
recordkeeping burden of 1 hour is based
on previous estimates for the
recordkeeping requirements associated
with the AER system.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR Section
601.6(a) ......................................................................
Annual
disclosures per
respondent
1
Total annual
disclosures
20
Average burden
per disclosure
20
0.33
Total hours 2
7
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The numbers in this column have been rounded to the nearest whole number.
Dated: October 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–26064 Filed 10–27–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0796]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
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18:12 Oct 27, 2016
Jkt 241001
public comment in response to the
notice. This notice solicits comments on
communication studies involving
medical devices and radiation-emitting
products regulated by FDA. This
information will be used to explore
concepts of interest and assist in the
development and modification of
communication messages and
campaigns to fulfill the Agency’s
mission to protect the public health.
DATES: Submit either electronic or
written comments on the collection of
information by December 27, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
PO 00000
Frm 00109
Fmt 4703
Sfmt 4703
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0796 for ‘‘Agency Information
Collection Activities; Proposed
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 81, Number 209 (Friday, October 28, 2016)]
[Notices]
[Pages 75130-75134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26064]
-----------------------------------------------------------------------
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, and Postmarketing
Studies Status Reports
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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
November 28, 2016.
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.
[[Page 75131]]
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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 Form FDA 356h OMB
Control Number 0910-0338--Extension
Under Section 351 of the Public Health Services 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 (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.
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 License 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 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.
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.
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), (2), and (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), (2), and (3) (labeling
supplements and annual reports) in table 1.
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, 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
[[Page 75132]]
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. The
burden estimates associated with Sec. 809.10 are approved under OMB
control number 0910-0485.
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 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 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 postmarking
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) 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.
Under Sec. 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 licensed 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;
therefore, the burden estimate for Sec. 640.120 is included in the
estimate under Sec. 601.12(b) in table 1.
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.
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
[[Page 75133]]
estimated burden hours for nonbiological product submissions to CDER
using FDA Form 356h are approved under OMB control number 0910-0001 (an
estimated 3,200 submissions x24 hours = 76,800 hours).
For advertisements and promotional labeling (e. g., circulars,
package labels, container labels, etc.) and labeling changes,
manufacturers of licensed biological products may submit to CBER or
CDER Form FDA 2253. In August of 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 can also be submitted electronically. Form FDA 2253 is
approved under OMB control number 0910-0001.
Respondents to this collection of information are manufacturers of
biological products. Under tables 1 and 2, 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 (FY) 2015. Based on information obtained
from FDA's database systems, there are an estimated 391 licensed
biologics manufacturers. The total annual responses are based on the
estimated number of submissions (i.e., license applications, labeling
and other 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 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 section 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. In table 1, FDA is
estimating 1 in case a suspension occurs.
Under Sec. Sec. 601.12(f)(4) and 601.45, manufacturers of
biological products may use Form FDA 2253 to submit advertising and
promotional labeling (which can include multiple pieces). Based on
information obtained from FDA's database system, there were an
estimated 11,676 submissions using Form FDA 2253 of advertising and
promotional labeling from 114 respondents.
Under Sec. Sec. 601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x3 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). For FY 2015, there were 139 reports from 82
respondents.
Under Sec. 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 2,777 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
In the Federal Register of July 11, 2016 (81 FR 44868), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \10\
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a) \2\, 610.60 through 610.65 \3\... 356h 28 1.36 38 860.......................... 32,680
601.5(a).................................. NA 12 0.75 9 0.33 (20 minutes)............ 3
601.6(a).................................. NA 1 1 1 0.33 (20 minutes)............ 1
601.12(a)(5).............................. NA 537 24.41 13,106 1............................ 13,106
601.12(b)(1)/(b)(3)/(e) \4\............... \2\ 356h 164 3.66 600 80........................... 48,000
601.12(c)(1)/(c)(3) \5\................... \2\ 356h 120 4.78 574 50........................... 28,700
601.12(c)(5).............................. \2\ 356h 7 1.14 8 50........................... 400
601.12(d)(1)/(d)(3) \6\/(f)(3) \8\........ \2\ 356h 246 3.34 822 24........................... 19,728
601.12(f)(1) \7\.......................... 2253 72 1.93 139 40........................... 5,560
601.12(f)(2) \ 7\......................... 2253 60 1.82 109 20........................... 2,180
601.12(f)(4)/601.45 \9\................... 2253 114 102.42 11,676 10........................... 116,670
601.27(b)................................. NA 20 16.50 330 24........................... 7,920
601.27(c)................................. NA 12 1.08 13 8............................ 104
601.70(b) and (d)/601.28.................. 2252 82 1.70 139 24........................... 3,336
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 125 22.22 2,777 20........................... 55,540
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[[Page 75134]]
Total................................. .............. .............. ............. .............. ............................. 333,949
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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), 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), 640.74(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), 610.53(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.
\10\ The numbers in this column have been rounded to the nearest whole number.
Under table 2, the estimated recordkeeping burden of 1 hour is
based on previous estimates for the recordkeeping requirements
associated with the AER system.
Table 2--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of disclosures per Total annual Average burden Total hours \2\
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a)........................................................... 1 20 20 0.33 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The numbers in this column have been rounded to the nearest whole number.
Dated: October 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26064 Filed 10-27-16; 8:45 am]
BILLING CODE 4164-01-P
