Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h, 44868-44872 [2016-16352]
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44868
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0578]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Form FDA 356h
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
public comment in response to the
notice. This notice solicits comments on
the collection of information relating to
general licensing provisions for
biologics license applications (BLAs),
changes to an approved application,
labeling, revocation and suspension,
postmarketing studies status reports,
and Form FDA 356h.
DATES: Submit electronic or written
comments on the collection of
information by September 9, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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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
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
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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–0578 for ‘‘General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports and Form FDA 356h.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
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information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
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Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices
of automated collection techniques,
when appropriate, and other forms of
information technology.
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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 No. 0910–0338—Extension
Under section 351 of the Public
Health Services 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 (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 §§ 610.60 through
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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 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) and (3), (c)(1),
(3), and (5), and (d)(1) and (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 (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) through (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.
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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) through (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
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.
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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
§ 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
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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
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
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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)
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
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).
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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
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 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 one in case
a suspension occurs.
Under §§ 601.12(f)(4) and 601.45,
manufacturers of biological products
may use Form FDA 2253 to submit
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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 §§ 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 1
respondent and 1 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours 10
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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) ......................
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 ..........
356h ...................
N/A .....................
N/A .....................
N/A .....................
356h 2 .................
356h 2 .................
356h 2 .................
356h 2 .................
2253 ...................
2253 ...................
2253 ...................
N/A .....................
N/A .....................
2252 ...................
N/A .....................
N/A .....................
N/A .....................
356h ...................
28
12
1
537
164
120
7
246
72
60
114
20
12
82
1
9
1
125
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
38
9
1
13,108
600
574
8
822
139
109
11,676
330
13
139
1
9
1
2,777
860 .....................
0.33 (20 minutes)
1 .........................
1 .........................
80 .......................
50 .......................
50 .......................
24 .......................
40 .......................
20 .......................
10 .......................
24 .......................
8 .........................
24 .......................
1 .........................
2 .........................
2 .........................
20 .......................
32,680
3
1
13,108
48,000
28,700
400
19,728
5,560
2,180
116,670
7,920
104
3,336
1
18
2
55,540
Total .........................................
............................
........................
........................
........................
............................
333,951
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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), 640.70(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.
2 The
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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 (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
21 CFR section
Number of
respondents
Annual
disclosures
per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours 2
601.6(a) ..................................................
1
20
20
0.33 (20 minutes) ........................
7
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
to the nearest whole number.
2 Rounded
Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16352 Filed 7–8–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Controlling the Progression of Myopia:
Contact Lenses and Future Medical
Devices; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA), in cosponsorship
with the American Academy of
Ophthalmology (AAO), American
Academy of Optometry (AAOpt),
American Association for Pediatric
Ophthalmology and Strabismus
(AAPOS), American Optometric
Association (AOA), American Society of
Cataract and Refractive Surgery
(ASCRS), and Contact Lens Association
of Ophthalmologists, Inc. (CLAO) is
announcing a public workshop entitled
‘‘Controlling the Progression of Myopia:
Contact Lenses and Future Medical
Devices.’’ The purpose of this workshop
is to discuss the increasing prevalence
of myopia, as well as suggested clinical
trial design attributes for studies using
contact lenses or other medical devices
to control the progression of myopia.
DATES: The public workshop will be
held on September 30, 2016, from 8 a.m.
sradovich on DSK3GDR082PROD with NOTICES
SUMMARY:
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to 6 p.m. Pickup of materials will begin
at 7:30 a.m.
ADDRESSES: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Conference Center, the Great Room,
(Rm. 1503), Silver Spring, MD, 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Michelle Tarver, Office of Device
Evaluation, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2504, Silver Spring,
MD 20993, 301–796–6884.
SUPPLEMENTARY INFORMATION:
starting interventions in childhood. The
literature suggests that myopia
progression is most rapid between 6 and
11 years of age and manipulating
peripheral retinal image quality may be
a treatment strategy to control axial
length and therefore the progression of
myopia. The results of studies
conducted with specialized contact
lenses, both rigid and soft, have
indicated that this approach may reduce
the rate of myopic progression in
children. As research into myopia
control is continuing at a rapid pace,
accompanying potential safety and
effectiveness questions also have
emerged. To ensure that the studies
conducted provide information that can
adequately inform the regulatory
review, we are conducting a workshop
to answer questions about the
appropriate clinical trial design and
outcomes for these devices.
I. Background
The prevalence of myopia in the
United States has increased over the
past decade with approximately 24
percent (over 30 million) of adults over
40 years of age being affected. Recent
studies have found the overall
prevalence of myopia to be 1.2 percent
among non-Hispanic White children,
6.6 percent in African Americans, 3.7
percent in Hispanic, and 3.98 percent in
Asian children. Pathologic myopia is
the third most frequent cause of
blindness due to retinal detachments or
abnormal blood vessel growth. Given
these potentially poor outcomes with
high myopia, researchers have sought
ways to prevent its development by
Topics to be discussed at the public
workshop include, but are not limited to
the following topics:
• Myopia Demographics.
• Contact Lens Use and Safety in a
Pediatric Population.
• Contact Lens Behaviors and
Hygiene.
• Studies Conducted on Myopia
Control Devices and Their Challenges.
• Regulation of Contact Lenses
(Ref. 1).
• Patient/Caregiver Perspectives and
the Role in Trial Design and Conduct
(Refs. 2 and 3).
We will also have a panel discussion
to address questions related to the
design of these clinical trials.
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]]>Agencies
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44868-44872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16352]
[[Page 44868]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0578]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation
and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
relating to general licensing provisions for biologics license
applications (BLAs), changes to an approved application, labeling,
revocation and suspension, postmarketing studies status reports, and
Form FDA 356h.
DATES: Submit electronic or written comments on the collection of
information by September 9, 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 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-0578 for ``General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation
and Suspension, Postmarketing Studies Status Reports and Form FDA
356h.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use
[[Page 44869]]
of automated collection techniques, when appropriate, and other forms
of information technology.
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 No. 0910-0338--Extension
Under section 351 of the Public Health Services 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 (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 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) and (3), (c)(1), (3), and (5), and (d)(1) and
(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 (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) through (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) through (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 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.
[[Page 44870]]
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. Sec.
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 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) 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 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 x 24 hours = 76,800
hours).
[[Page 44871]]
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 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 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 one 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 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). 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 1 respondent and 1 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Form FDA No. Number of responses per Total annual Average burden per Total hours
respondents respondent responses response \10\
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601.2(a) \2\, 610.60 through 610.65 356h.................... 28 1.36 38 860.................... 32,680
\3\.
601.5(a)............................. N/A..................... 12 0.75 9 0.33 (20 minutes)...... 3
601.6(a)............................. N/A..................... 1 1 1 1...................... 1
601.12(a)(5)......................... N/A..................... 537 24.41 13,108 1...................... 13,108
601.12(b)(1)/(b)(3)/(e).............. 356h \2\................ 164 3.66 600 80..................... 48,000
601.12(c)(1)/(c)(3) \5\.............. 356h \2\................ 120 4.78 574 50..................... 28,700
601.12(c)(5)......................... 356h \2\................ 7 1.14 8 50..................... 400
601.12(d)(1)/(d)(3) \6\/(f)(3) \8\... 356h \2\................ 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)............................ N/A..................... 20 16.50 330 24..................... 7,920
601.27(c)............................ N/A..................... 12 1.08 13 8...................... 104
601.70(b) and (d)/601.28............. 2252.................... 82 1.70 139 24..................... 3,336
610.15(d)............................ N/A..................... 1 1 1 1...................... 1
680.1(c)............................. N/A..................... 9 1 9 2...................... 18
680.1(b)(3)(iv)...................... N/A..................... 1 1 1 2...................... 2
Amendments/Resubmissions............. 356h.................... 125 22.22 2,777 20..................... 55,540
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Total............................ ........................ .............. .............. .............. ....................... 333,951
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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), 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.
[[Page 44872]]
\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 (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\
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Annual
21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours \2\
respondents respondent disclosures
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601.6(a)........................................ 1 20 20 0.33 (20 minutes)................. 7
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest whole number.
Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16352 Filed 7-8-16; 8:45 am]
BILLING CODE 4164-01-P
