Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h, 3053-3057 [2020-00729]
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FOR FURTHER INFORMATION CONTACT:
Patricio G. Garcia, Division of
Management Services, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216,
Silver Spring, MD 20993–0002, 301–
796–6875, email: Patricio.Garcia@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members on TEPRSSC that include
three general public representatives.
I. General Description of the
Committee’s Duties
The committee provides advice and
consultation to the Commissioner of
Food and Drugs (Commissioner) on the
technical feasibility, reasonableness,
and practicability of performance
standards for electronic products to
control the emission of radiation from
such products, and may recommend
electronic product radiation safety
standards to the Commissioner for
consideration.
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II. Criteria for Voting Members
The committee consists of a core of 15
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of science or engineering,
applicable to electronic product
radiation safety. Members will be
invited to serve for overlapping terms of
up to 4 years. Terms of more than 2
years are contingent upon the renewal
of the committee by appropriate action
prior to its expiration.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the committee. Selfnominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address and/or home address,
telephone number, and email address if
available and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
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This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00733 Filed 1–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0578]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Form FDA 356h
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 February
18, 2020.
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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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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 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 of
1997 (Pub. L. 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(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) (21 CFR 601.2(a))
requires a manufacturer of a biological
product to submit an application on
forms prescribed for such purposes with
accompanying data and information,
including certain labeling information,
to FDA for approval to market a product
in interstate commerce. The container
and package labeling requirements are
provided under §§ 610.60 through
610.65 (21 CFR 610.60 through 610.65).
The estimate for these regulations is
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included in the estimate under
§ 601.2(a) in table 1.
Section 601.5(a) (21 CFR 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) (21 CFR
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) (21 CFR
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) 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 (21 CFR 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 (21 CFR 601.45)
requires applicants of biological
products for serious or life-threatening
illnesses to submit to the Agency for
consideration, during the preapproval
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) (21 CFR 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 paragraph 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) (21 CFR 640.84(a) and (c)) for
Albumin; § 640.94(a) (21 CFR 640.94(a))
for Plasma Protein Fraction; § 660.2(c)
(21 CFR 660.2(c)) for Antibody to
Hepatitis B Surface Antigen; § 660.28(a)
through (c) (21 CFR 660.28(a) through
(c)) for Blood Grouping Reagent;
§ 660.35(a) through (d) (21 CFR
660.35(a) through (d)) for Reagent Red
Blood Cells; § 660.45 (21 CFR 660.45)
for Hepatitis B Surface Antigen; and
§ 660.55(a) and (b) (21 CFR 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 § 809.10 (21 CFR
PO 00000
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Fmt 4703
Sfmt 4703
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) (21 CFR 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 because these
regulations deal with information to be
provided in an application.
Section 601.28 (21 CFR 601.28)
requires sponsors of licensed biological
products to submit the information in
§ 601.28(a) through (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 (21 CFR 601.70) rather
than under this section.
Sections 601.33 through 601.35 (21
CFR 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 because 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 (21
CFR 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 part 601, subpart H are
subject to the postmarketing
recordkeeping and safety reporting
applicable to all approved biological
products. Section 601.94 requires
applicants under part 601, subpart H to
submit to the Agency for consideration
during the preapproval review period
copies of all promotional materials
including promotional labeling as well
as advertisements. Under §§ 601.91(b)(2)
and 601.93, any potential postmarketing
reports and/or recordkeeping burdens
would be included under the adverse
experience reporting (AER)
requirements under 21 CFR part 600
(OMB control number 0910–0308).
Therefore, any burdens associated with
these requirements would be reported
under the AER information collection
requirements (OMB control number
0910–0308). The burden estimate for
§ 601.91(b)(3) is included in the
estimate under §§ 610.60 through
610.65.
Section 610.9(a) (21 CFR 610.9(a))
requires the applicant to present certain
information, in the form of a license
application or supplement to the
application, for a modification of any
particular test method or manufacturing
process or the conditions under which
it is conducted under the biologics
regulations. The burden estimate for
§ 610.9(a) is included in the estimate
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under §§ 601.2(a) and 601.12(b) and (c)
in table 1.
Under § 610.15(d) (21 CFR 610.15(d)),
the Director of CBER or the Director of
CDER may approve, as appropriate, a
manufacturer’s request for exceptions or
alternatives to the regulation for
constituent materials. Manufacturers
seeking approval of an exception or
alternative must submit a request in
writing with a brief statement describing
the basis for the request and the
supporting data.
Section 640.120 (21 CFR 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(b) (21
CFR 600.15(b) and 610.53(b)) 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(b), 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.
Form FDA 356h, ‘‘Application to
Market a New or Abbreviated New Drug
or Biologic for Human Use,’’ is used for
the applicable submissions to both
CBER and CDER. The application form
serves primarily as a checklist for firms
to gather and submit certain information
to FDA and 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
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Sfmt 4703
3055
the appropriate staff for review. FDA
estimates an average of 24 hours to
complete the application form, which is
included in the average burden per
response. The estimated burden hours
for nonbiological product submissions
to CDER using Form FDA 356h are
approved under OMB control number
0910–0001 (an estimated 16,650
submissions × 24 hours = 399,600
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. 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 table 1, 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 2018. Based on information
obtained from FDA’s database systems,
there are an estimated 424 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
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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
advertising and promotional labeling
(which can include multiple pieces).
Based on information obtained from
FDA’s database system, the estimate is
based on the number of submissions
received using Form FDA 2253 for
advertising and promotional labeling.
Under §§ 601.28 and 601.70(b), FDA
estimates that it takes an applicant
approximately 24 hours (8 hours per
study × 3 studies) annually to gather,
complete, and submit the appropriate
information for each postmarketing
status report (approximately 2 to 4
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).
Under § 610.15(d), FDA has received
no submissions since the
implementation of the final rule
(‘‘Revision of the Requirements for
Constituent Materials’’) in April 2011
(76 FR 20513, April 13, 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 3,398
amendments to an unapproved
application or supplement and
resubmissions submitted using Form
FDA 356h.
In the Federal Register of September
19, 2019 (84 FR 49310), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
Number of
respondents
Form FDA No.
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours 10
601.2(a) ,2 610.60 through 610.65 3 .........
601.5(a) ....................................................
601.6(a) ....................................................
601.12(a)(5) ..............................................
601.12(b)(1) and (3) and (e) 4 ..................
601.12(c)(1) and (3) 5 ...............................
601.12(c)(5) ..............................................
601.12(d)(1) and (3) 6 and (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
NA
NA
NA
2 356h
2 356h
2 356h
2 356h
2253
2253
2253
NA
NA
2252
NA
NA
NA
356h
36
8
1
430
166
149
7
245
65
43
134
12
2
65
1
9
1
136
1.28
1.13
1
4.158
4.843
4.58
1.14
3.575
3.169
2.05
145.86
1.08
1
3.169
1
1
1
24.985
46
9
1
1,788
804
682
8
876
206
88
19,545
13
2
206
1
9
1
3,398
860 ........................
0.33 (20 minutes) ..
0.33 (20 minutes) ..
1 ............................
80 ..........................
50 ..........................
50 ..........................
24 ..........................
40 ..........................
20 ..........................
10 ..........................
24 ..........................
8 ............................
24 ..........................
1 ............................
2 ............................
2 ............................
20 ..........................
39,560
3
1
1,788
64,320
34,100
400
21,024
8,240
1,760
195,450
312
16
4,944
1
18
2
67,960
Total ..................................................
........................
........................
........................
........................
...............................
439,899
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), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) through (c),
660.35(a) through (d), 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(b), 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.
2 The
lotter on DSKBCFDHB2PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours 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.
2 The number in this column has been rounded to the nearest whole number.
Our estimated burden for the
information collection reflects an
overall increase of 105,948 hours and a
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18:20 Jan 16, 2020
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corresponding decrease of 2,671
responses. We attribute this adjustment
in the total hours to an increase in the
PO 00000
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number of submissions we have
received under §§ 601.12(b)(1) and (3),
(e), and (f)(4), and 601.45 over the last
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Federal Register / Vol. 85, No. 12 / Friday, January 17, 2020 / Notices
few years. We attribute the decrease in
total annual responses to a decrease in
responses received under §§ 601.12(a)(5)
and 601.27(b) over the last few years.
Dated: January 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00729 Filed 1–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Maternal, Infant, and Early
Childhood Home Visiting Program
Home Visiting Budget Assistance Tool,
OMB No. 0906–0025—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this Notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than February 18,
2020.
DATES:
Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Maternal, Infant, and Early Childhood
Home Visiting Program Home Visiting
lotter on DSKBCFDHB2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
18:20 Jan 16, 2020
Jkt 250001
Budget Assistance Tool, OMB No. 0906–
0025—Revision.
Abstract: HRSA is requesting
continued approval of the Home
Visiting Budget Assistance Tool (HV–
BAT), as modified by HRSA in response
to further testing and public comments,
as further described below. The tool
collects information on standardized
cost metrics from programs that deliver
home visiting services, as outlined in
the HV–BAT. During Fiscal Year (FY)
2020, prior to required use of the tool
by awardees starting in FY 2021, HRSA
intends to conduct a follow-up study to
test the feasibility of the HV–BAT for
universal implementation across
Maternal, Infant, and Early Childhood
Home Visiting (MIECHV) programs and
the tool’s capacity to support program
planning, budget forecasting, fiscal subrecipient monitoring and to estimate
national program costs. In addition,
HRSA will investigate the necessary
resources and support for successful
execution of the HV–BAT prior to
initiating the reporting requirement.
Upon successful completion of the FY
2020 feasibility study, beginning in FY
2021, HRSA will require reporting of
HV–BAT data for one-third of awardees
in each 3-year cycle, resulting in
collection of data from all awardees over
a 3-year time period, to inform program
planning and budgeting.
The MIECHV Program, authorized by
section 511 of the Social Security Act,
42 U.S.C. 711, and administered by
HRSA in partnership with the
Administration for Children and
Families, supports voluntary, evidencebased home visiting services during
pregnancy and to parents with young
children up to kindergarten entry.
States, Tribal entities, and certain
nonprofit organizations are eligible to
receive funding from the MIECHV
Program and have the flexibility to tailor
the program to serve the specific needs
of their communities. Funding
recipients may subaward grant funds to
local implementing agencies (LIAs) in
order to provide services to eligible
families in at-risk communities.
HRSA is revising its originally
described HV–BAT data collection
purpose. Original clearance under this
OMB control number was for pilot
testing the reliability of a standardized
cost-reporting tool among evidencebased home visiting programs. HRSA
has revised the data collection tool to
reflect findings and recommendations
from the pilot study and in response to
public comments to ensure clarity,
usability and fidelity, including changes
to instructions, definitions and
estimated burden.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
3057
A 60-day notice was published in the
Federal Register on August 1, 2019, vol.
84, No. 148, pp. 37655–56. There were
eight public comments.
HRSA announced a 60-day public
comment period to solicit input on its
HV–BAT data collection efforts. In
response to this notice, HRSA received
feedback on the following aspects:
• Utilization of Data Collection
• Documentation and Reporting
Requirements
• Accuracy of the Estimated Burden
• Implementation
HRSA carefully reviewed the
comments received and used them to
guide the development of the a followup HV–BAT feasibility study to be
conducted in FY 2020 that will further
inform the FY 2021 HV–BAT reporting
requirements.
Responses to Comments on the
Proposed MIECHV HV–BAT
HRSA received eight responses to the
request for public comment. Four
commenters are current MIECHV
awardees, two are home visiting model
developers, one is a national
association, and one is an individual
respondent. Comments are summarized
below.
Utilization of Data Collection
Summary of Comments
Commenters expressed concern over
the utility of the HV–BAT as a budget
planning tool and its ability to account
for variables that differ across models,
program populations, providers and
settings which could impact cost
comparisons. In addition, respondents
requested more information on the
intended long-term use of the HV–BAT
data.
Response
HRSA intends the HV–BAT to inform
future budget planning, monitoring, and
review of the costs of implementing
home visiting at the LIA level in a state
and support other programmatic
priorities such as cost-benefit analysis
and reimbursement policies. The tool in
its current state provides information to
permit calculation of certain cost
metrics, such as cost per family, which
can be used to assist in program
planning and budget forecasting.
Further, the HV–BAT feasibility study
will examine the use of the HV–BAT to
conduct cost benefit calculations. The
feasibility study will also examine how
the HV–BAT accounts for other types of
cost variation, such as cost of living and
inflation. Information collected in the
feasibility study will be used to
establish standards for implementation.
E:\FR\FM\17JAN1.SGM
17JAN1
]]>Agencies
[Federal Register Volume 85, Number 12 (Friday, January 17, 2020)]
[Notices]
[Pages 3053-3057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0578]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Licensing
Provisions: Biologics License Application, Changes to an Approved
Application, Labeling, Revocation and Suspension, Postmarketing Studies
Status Reports, and Form FDA 356h
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
February 18, 2020.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0338.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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 of 1997 (Pub. L. 105-115) amended the Federal Food, Drug, and
Cosmetic Act (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) (21 CFR 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
[[Page 3054]]
included in the estimate under Sec. 601.2(a) in table 1.
Section 601.5(a) (21 CFR 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) (21 CFR 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) (21 CFR 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) 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 (21 CFR 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 (21 CFR 601.45) requires applicants of biological
products for serious or life-threatening illnesses to submit to the
Agency for consideration, during the preapproval 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) (21
CFR 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 paragraph 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)
(21 CFR 640.84(a) and (c)) for Albumin; Sec. 640.94(a) (21 CFR
640.94(a)) for Plasma Protein Fraction; Sec. 660.2(c) (21 CFR
660.2(c)) for Antibody to Hepatitis B Surface Antigen; Sec. 660.28(a)
through (c) (21 CFR 660.28(a) through (c)) for Blood Grouping Reagent;
Sec. 660.35(a) through (d) (21 CFR 660.35(a) through (d)) for Reagent
Red Blood Cells; Sec. 660.45 (21 CFR 660.45) for Hepatitis B Surface
Antigen; and Sec. 660.55(a) and (b) (21 CFR 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 Sec. 809.10 (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) (21 CFR 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 because these regulations deal
with information to be provided in an application.
Section 601.28 (21 CFR 601.28) requires sponsors of licensed
biological products to submit the information in Sec. 601.28(a)
through (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 (21 CFR 601.70)
rather than under this section.
Sections 601.33 through 601.35 (21 CFR 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
[[Page 3055]]
Sec. 601.2(a) in table 1 because 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 (21 CFR 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 part 601, subpart H are subject to the postmarketing
recordkeeping and safety reporting applicable to all approved
biological products. Section 601.94 requires applicants under part 601,
subpart H to submit to the Agency for consideration during the
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) (21 CFR 610.9(a)) requires the applicant to
present certain information, in the form of a license application or
supplement to the application, for a modification of any particular
test method or manufacturing process or the conditions under 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) (21 CFR 610.15(d)), the Director of CBER or
the Director of CDER may approve, as appropriate, a manufacturer's
request for exceptions or alternatives to the regulation for
constituent materials. Manufacturers seeking approval of an exception
or alternative must submit a request in writing with a brief statement
describing the basis for the request and the supporting data.
Section 640.120 (21 CFR 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(b) (21 CFR 600.15(b) and 610.53(b))
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(b), 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.
Form FDA 356h, ``Application to Market a New or Abbreviated New
Drug or Biologic for Human Use,'' is used for the applicable
submissions to both CBER and CDER. The application form serves
primarily as a checklist for firms to gather and submit certain
information to FDA and 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. FDA estimates an average of 24 hours to
complete the application form, which is included in the average burden
per response. The estimated burden hours for nonbiological product
submissions to CDER using Form FDA 356h are approved under OMB control
number 0910-0001 (an estimated 16,650 submissions x 24 hours = 399,600
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. 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 table 1, 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 2018. Based on information obtained from FDA's
database systems, there are an estimated 424 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
[[Page 3056]]
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, the estimate is based
on the number of submissions received using Form FDA 2253 for
advertising and promotional labeling.
Under Sec. Sec. 601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x 3 studies)
annually to gather, complete, and submit the appropriate information
for each postmarketing status report (approximately 2 to 4 studies per
report) and the accompanied transmittal Form FDA 2252. Included in
these 24 hours is the time necessary to prepare and submit two copies
of the annual progress report of postmarketing studies to FDA under
Sec. 601.70(d).
Under Sec. 610.15(d), FDA has received no submissions since the
implementation of the final rule (``Revision of the Requirements for
Constituent Materials'') in April 2011 (76 FR 20513, April 13, 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 3,398 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
In the Federal Register of September 19, 2019 (84 FR 49310), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section Form FDA No. Number of responses per Total annual Average burden per response hours
respondents respondent responses \10\
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a) ,\2\ 610.60 through 610.65 \3\. 356h 36 1.28 46 860................................ 39,560
601.5(a)................................ NA 8 1.13 9 0.33 (20 minutes).................. 3
601.6(a)................................ NA 1 1 1 0.33 (20 minutes).................. 1
601.12(a)(5)............................ NA 430 4.158 1,788 1.................................. 1,788
601.12(b)(1) and (3) and (e) \4\........ \2\ 356h 166 4.843 804 80................................. 64,320
601.12(c)(1) and (3) \5\................ \2\ 356h 149 4.58 682 50................................. 34,100
601.12(c)(5)............................ \2\ 356h 7 1.14 8 50................................. 400
601.12(d)(1) and (3) \6\ and (f)(3) \8\. \2\ 356h 245 3.575 876 24................................. 21,024
601.12(f)(1) \7\........................ 2253 65 3.169 206 40................................. 8,240
601.12(f)(2) \7\........................ 2253 43 2.05 88 20................................. 1,760
601.12(f)(4)/601.45 \9\................. 2253 134 145.86 19,545 10................................. 195,450
601.27(b)............................... NA 12 1.08 13 24................................. 312
601.27(c)............................... NA 2 1 2 8.................................. 16
601.70(b) and (d)/601.28................ 2252 65 3.169 206 24................................. 4,944
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 136 24.985 3,398 20................................. 67,960
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Total............................... .............. .............. .............. .............. ................................... 439,899
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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), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) through (c),
660.35(a) through (d), 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(b), 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.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section Number of disclosures per Total annual Average burden 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\ The number in this column has been rounded to the nearest whole number.
Our estimated burden for the information collection reflects an
overall increase of 105,948 hours and a corresponding decrease of 2,671
responses. We attribute this adjustment in the total hours to an
increase in the number of submissions we have received under Sec. Sec.
601.12(b)(1) and (3), (e), and (f)(4), and 601.45 over the last
[[Page 3057]]
few years. We attribute the decrease in total annual responses to a
decrease in responses received under Sec. Sec. 601.12(a)(5) and
601.27(b) over the last few years.
Dated: January 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00729 Filed 1-16-20; 8:45 am]
BILLING CODE 4164-01-P
