Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567, 32786-32790 [2010-13815]
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EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST—Continued
Cost component
Total cost
Total ..................................................................................................................................................................
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: May 28, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–13728 Filed 6–8–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2010–N–0019]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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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 July 9,
2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0338. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567 (OMB Control Number 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
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1,800,000
Annualized
cost
900,000
prescribed by regulations in part 601 (21
CFR Part 601).
Section 130(a) of the Food and Drug
Administration Modernization Act
(Public Law 105–115) amended the
Federal Food, Drug, and Cosmetic Act
(the act) by adding a new provision
(section 506B of the act (21 U.S.C.
356b)) requiring reports of
postmarketing studies for approved
human drugs and licensed biological
products. Section 506B of the 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 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 additional collection of
information requirements follows.
Section 601.2(a) requires a
manufacturer of a biological product to
submit an application on forms
prescribed for such purposes with
accompanying data and information,
including certain labeling information,
to FDA for approval to market a product
in interstate commerce. The container
and package labeling requirements are
provided under §§ 610.60 through
610.65. The estimate for these
regulations is included in the estimate
under § 601.2(a) in table 1 of this
document.
Section 601.5(a) requires a
manufacturer to submit to FDA notice of
its intention to discontinue manufacture
of a product or all products. Section
601.6(a) requires the manufacturer to
notify selling agents and distributors
upon suspension of its license, and
provide FDA of such notification.
Section 601.12 (a)(2) requires,
generally, that the holder of an
approved 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
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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 of
this document.
Sections 601.12(b)(1) and (b)(3), (c)(1)
and (c)(3), and (c)(5), and (d)(1) and
(d)(3) require applicants to follow
specific procedures to submit
information to FDA of any changes, in
the product, production process, quality
controls, equipment, facilities, or
responsible personnel established in an
approved license application. The
appropriate procedure depends on the
potential for the change to have a
substantial, moderate, or minimal
adverse effect on the identity, strength,
quality, purity, or potency of the
products as they may relate to the safety
or effectiveness of the product. Under
§ 601.12(b)(4), an applicant may ask
FDA to expedite its review of a
supplement for public health reasons or
if a delay in making the change
described in it would impose an
extraordinary hardship of the applicant.
The burden estimate for § 601.12(b) (4)
is minimal and included in the estimate
under § 601.12(b)(1) and (b)(3) in table
1 of this document.
Section 601.12(e) requires applicants
to submit a protocol, or change to a
protocol, as a supplement requiring
FDA approval before distributing the
product. Section 601.12(f)(1), (f)(2), and
(f)(3) requires applicants to follow
specific procedures to report certain
labeling changes to FDA. Section
601.12(f)(4) requires applicants to report
to FDA advertising and promotional
labeling and any changes.
Under section 601.14, the content of
labeling required in § 201.100(d)(3)
must be in electronic format and in a
form that FDA can process, review, and
archive. This requirement is in addition
to the provisions of §§ 601.2(a) and
601.12(f). The burden estimate for
§ 601.14 is minimal and included in the
estimate under §§ 601.2(a) (BLAs) and
601.12(f)(1), (f)(2), and (f)(3) (labeling
supplements and annual reports) in
table 1 of this document.
Section 601.45 requires applicants of
biological products for serious or lifethreatening illnesses to submit to the
agency for consideration, during the
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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),
680.1(b)(2)(iii), and 680.1(d). In table 1
of this document, the burden associated
with the information collection
requirements in these 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: § 640.70(a) for Source
Plasma; § 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 § 809.10. Therefore, the
burden estimates for these regulations
are included in the estimate under
§§ 610.60 through 610.65 in table 1 of
this document. The burden estimates
associated with § 809.10 are approved
under OMB Control No. 0910–0485.
Section 601.25(b) requests interested
persons to submit, for review and
evaluation by an advisory review panel,
published and unpublished data and
information pertinent to a designated
category of biological products that have
been licensed prior to July 1, 1972.
Section 601.26(f) requires that licensees
submit to FDA a written statement
intended to show that studies adequate
and appropriate to resolve the questions
raised about a biological product have
been undertaken for a product if
designated as requiring further study
under the reclassification procedures.
Under § 601.25(b), FDA estimates no
PRA burden for this regulation, and
therefore this regulation is not included
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32787
in table 1 of this document. Under
section 601.26(f), FDA estimates no
burden for this regulation since there
are no products designated to require
further study and none are predicted in
the future. However, FDA is using an
estimate of 1 for calculation purposes.
Based on the possible reclassification of
a product, the labeling for the product
may need to be revised, or a
manufacturer, on its own initiative, may
deem it necessary for further study. As
a result, any changes to product labeling
would be reported under the
appropriate subsection of § 601.12.
Section 601.27(a) requires that
applications for new biological products
contain data that are adequate to assess
the safety and effectiveness of the
biological product for the claimed
indications in pediatric subpopulations,
and to support dosing and
administration information. Section
601.27(b) provides that an applicant
may request a deferred submission of
some or all assessments of safety and
effectiveness required under § 601.27(a)
until after licensing the product for use
in adults. Section 601.27(c) provides
that an applicant may request a full or
partial waiver of the requirements under
§ 601.27(a) with adequate justification.
The burden estimates for § 601.27(a) are
included in the burden estimate under
§ 601.2(a) in table 1 of this document
since these regulations deal with
information to be provided in an
application.
Section 601.28 requires sponsors of
licensed biological products to submit
the information in § 601.28(a), (b), and
(c) to the Center for Biologics Evaluation
and Research (CBER) or 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 then under this
section.
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Sections 601.33 through 601.35 clarify
the information to be submitted in an
application to FDA to evaluate the
safety and effectiveness of in vivo
radiopharmaceuticals. The burden
estimates for §§ 601.33 through 601.35
are included in the burden estimate
under § 601.2(a) in table 1 of this
document 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
No. 0910–0001). Under § 601.70(d), two
copies of the annual report shall be
submitted to FDA.
Section 601.91 through 601.94
concerns biological products for which
human efficacy studies are not ethical or
feasible. Section 601.91(b)(3) requires
applicants to prepare and provide
labeling with relevant information to
patient or potential patient for biological
products approved under the subpart
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 this
subpart are subject to the postmarketing
recordkeeping and safety reporting
applicable to all approved biological
products. Section 601.94 requires
applicants under this subpart to submit
to the agency for consideration during
preapproval review period copies of all
promotional materials including
promotional labeling as well as
advertisements.
Under § 601.93, 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 No. 0910–
0308). Therefore, any burdens
associated with these requirements
would be reported under the AER
information collection requirements
(OMB Control No. 0910–0308).
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 of this document.
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Section 610.11(g)(2) provides that a
manufacturer of certain biological
products may request an exemption
from the general safety test (GST)
requirements contained in this subpart.
Under § 610.11(g)(2), FDA requires only
those manufacturers of biological
products requesting an exemption from
the GST to submit additional
information as part of a license
application or supplement to an
approved license application. Therefore,
the burden estimate for § 610.11(g)(2) is
included in the estimate under
§§ 601.2(a) and 601.12(b) in table 1 of
this document.
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. 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 of this
document.
Section 680.1(c) requires
manufacturers to update annually their
license file with the list of source
materials and the suppliers of the
materials. Section 680.1(b)(3)(iv)
requires manufacturers to notify FDA
when certain diseases are detected in
source materials.
Sections 600.15(b) and 610.53(d)
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) requires
the submission of a request for approval
to perform plasmapheresis of donors
who do not meet certain donor
requirements for the collection of
plasma containing rare antibodies.
Under §§ 600.15(b), 610.53(d), and
606.110(b), a request for an exemption
or modification to the requirements
would be submitted as a supplement.
Therefore, the burden hours for any
submissions under §§ 600.15(b),
610.53(d), and 606.110(b) are included
in the estimates under § 601.12(b) in
table 1 of this document.
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. The
checklist helps to ensure that the
application is complete and contains all
the necessary information, so that
delays due to lack of information may
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be eliminated. 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 No. 0910–
0001.
Form FDA 2567 ‘‘Transmittal of
Labels and Circulars’’ is used by
manufacturers of licensed biological
products to submit labeling (e.g.,
circulars, package labels, container
labels, etc.) and labeling changes for
FDA review and approval. The labeling
information is submitted with the form
for license applications, supplements, or
as part of an annual report. Form FDA
2567 is also used for the transmission of
advertisements and promotional
labeling. Form FDA 2567 serves as an
easy guide to assure that the
manufacturer has provided the
information required for expeditious
handling of their labeling by CBER. For
advertisements and promotional
labeling, manufacturers of licensed
biological products may submit to CBER
either Form FDA 2567 or 2253. Form
FDA 2253 was previously used only by
drug manufacturers regulated by CDER.
In August 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
is approved under OMB Control No.
0910–0001.
Under table 1 of this document, the
number of respondents is 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) 2008. Based on
information obtained from FDA’s
database systems, there are an estimated
301 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. Based on
previous estimates, the rate of
submissions is not expected to change
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estimated annual number of
suspensions of a biologic license.
Under §§ 601.12(f)(4) and 601.45,
manufacturers of biological products
may use either Form FDA 2567 or Form
FDA 2253 to submit advertising and
promotional labeling. Based on
information obtained from FDA’s
database system, there were an
estimated 4,452 submissions of
advertising and promotional labeling.
FDA estimates that approximately 15%
of those submissions were received with
Form FDA 2567 and 85% were received
with Form 2253.
Under §§ 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 § 601.70(d).
Under §§ 601.91 through 601.94, FDA
expects to receive very few applications
significantly in the next few years. 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
for these products; however, for
calculation purposes, FDA is estimating
the annual submission of one
application. Under §§ 601.93(b)(3) and
601.94, FDA estimates 240 hours for a
manufacturer of a new biological
product to develop patient labeling, and
to submit the appropriate information
and promotional labeling to FDA. The
majority of the burden for developing
the patient labeling is included under
the reporting requirements for § 601.94,
therefore minimal burden is calculated
for providing the guide to patients
under § 601.91(b)(3).
There were a total of 5,338
amendments to an unapproved
application or supplement and
resubmissions submitted using Form
FDA 356h.
In the Federal Register of January 26,
2010 (75 FR 4081), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received on this information collection
request.
FDA estimates the burden of this
collection of information as follows:
TABLE 1. — ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
601.2(a)2, 610.60 through
610.653
Form FDA No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
2567/356h
23
2
46
860
39,560
601.5(a)
NA
11
3
33
20 minutes
11
601.6(a)
NA
1
21
21
20 minutes
7
601.12(a)(5)
NA
802
9
7,218
1
7,218
601.12(b)(1)/(b)(3)/(e)4
356h
2
166
5
830
80
66,400
601.12(c)(1)/(c)(3)5
356h
2
141
5
705
50
35,250
601.12(c)(5)
356h
2
42
5
210
50
10,500
601.12(d)(1)/(d)(3)/(f)(3)7
356h
2
246
3
738
23
16,974
601.12(f)(1)6
2567
112
2
224
40
8,960
601.12(f)(2)6
2567
53
3
159
20
3,180
2567/2253
42
106
4,452
10
44,520
601.26(f)
NA
1
1
1
1
1
601.27(b)
NA
6
1
6
24
144
601.27(c)
NA
10
1
10
8
80
2252
39
2
78
24
1,872
601.91(b)(3), 601.94
NA
1
1
1
240
240
680.1(c)
NA
9
1
9
2
18
680.1(b)(3)(iv)
NA
1
1
1
2
2
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601.12(f)(4)/601.45
601.70(b) and (d)/601.28
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TABLE 1. — ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
Form FDA No.
Amendments/Resubmissions
No. of
Respondents
356h
Annual Frequency
per Response
314
Total Annual
Responses
17
Hours per
Response
5,338
Total Hours
20
TOTAL
106,760
341,697
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
reporting requirements under §§ 610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a).
3 The reporting requirements under §§ 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c),
660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.65.
4 The reporting requirements under §§ 610.9(a), 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c),
640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b).
5 The reporting requirements under §§ 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 § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2).
7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3).
2 The
Under table 2 of this document, the
estimated recordkeeping burden of 1
hour is based on previous estimates for
the recordkeeping requirements
associated with the AER (Adverse Event
Reports) system.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Respondents
21 CFR Section
601.91(b)(2)(iii)
1 There
1
Total Annual
Responses
1
Hours per
Response
1
Total Hours
1
1
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Intended Recipients of the Award:
The 30 incumbent grantees (see list
below).
Amount of the Non-Competitive
Supplemental Funding: $97,500 per
grantee.
Authority: Section 501(c)(1) of the
Social Security Act, as amended.
CFDA Number: 93.110.
Project Period: June 1, 2010 through
May 31, 2011 for a total of 12 months.
[FR Doc. 2010–13815 Filed 6–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Discretionary Grant Program
AGENCY: Health Resources and Services
Administration (HRSA), HHS.
ACTION: Notice of Noncompetitive
Program Extension Supplemental
Awards.
erowe on DSK5CLS3C1PROD with NOTICES
Annual Frequency
per Response
SUMMARY: HRSA will be issuing noncompetitive supplemental funding
under the Maternal Child and Health
Bureau’s Family to Family Health
Information Centers Program. This will
provide feasible time for the Maternal
and Child Health Bureau (MCHB) to
align fiscal resources and programmatic
goals as outlined in changes that
emerged as a result of enactment of the
Patient Protection and Affordable Care
Act (Pub. L. 111–148) with the least
disruption to the States, communities,
and constituencies that currently
receive assistance and services from
these grantees.
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:10 Jun 08, 2010
Jkt 220001
Justification for the Exception to
Competition
The program provides grants to
family-run/staffed organizations to
ensure families of children with special
health care needs have access to
adequate information about health and
community resources to allow informed
decisions around their children’s health
care. Family to Family Health
Information Centers (F2F HICs) were
originally authorized under the Family
Opportunity Act as part of the Budget
Deficit Reduction Act of 2005; Pub. L.
109–171. Congress specified that there
be a family-run/staffed center in each
State and the District of Columbia by
June 2009. These centers, among other
tasks, were to assist families of children
with special health care needs to make
informed choices about health care in
order to promote good treatment
decisions, cost effectiveness and
improved health outcomes by providing
information and educational
opportunities for families, their health
professionals, schools, and other
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
appropriate entities. Awards were
staggered based upon available funding
with 30 grantees awarded in 2007 with
project periods ending May 31, 2010. As
the end of their project period quickly
approached and continued funding was
not provided in the President’s Budget
for fiscal year (FY) 2010, MCHB
prepared for closeout of the program.
Section 5507 of the Patient Protection
and Affordable Care Act (the Affordable
Care Act) extended the F2F HICs
through FY 2012. Therefore, the MCHB
will extend the project periods of the 30
aforementioned grants into FY 2011.
This will provide sufficient fiscal
resources to continue programmatic
activities as outlined in legislation with
the least disruption to the States,
communities, and the MCHB
constituencies that currently receive
assistance and services from these
grantees. The MCHB will also delay the
competition for these grants until FY
2011 to ensure continuity of funding for
all eligible entities, with no eligible
entity being adversely impacted by the
extension.
FOR FURTHER INFORMATION CONTACT:
LaQuanta Person, Project Officer,
Integrated Services Branch, Division of
Services for Children with Special
Health Needs, Maternal and Child
Health Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 18A–18, Rockville, MD
20857; 301.443.2370; lperson@hrsa.gov.
E:\FR\FM\09JNN1.SGM
09JNN1
]]>Agencies
[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Notices]
[Pages 32786-32790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13815]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0019]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; General Licensing
Provisions: Biologics License Application, Changes to an Approved
Application, Labeling, Revocation and Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h and 2567
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by July 9,
2010.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0338.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; General Licensing
Provisions: Biologics License Application, Changes to an Approved
Application, Labeling, Revocation and Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h and 2567 (OMB Control Number 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 (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic
Act (the act) by adding a new provision (section 506B of the act (21
U.S.C. 356b)) requiring reports of postmarketing studies for approved
human drugs and licensed biological products. Section 506B of the 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
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 additional 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. The estimate for these
regulations is included in the estimate under Sec. 601.2(a) in table 1
of this document.
Section 601.5(a) requires a manufacturer to submit to FDA notice of
its intention to discontinue manufacture of a product or all products.
Section 601.6(a) requires the manufacturer to notify selling agents and
distributors upon suspension of its license, and provide FDA of such
notification.
Section 601.12 (a)(2) requires, generally, that the holder of an
approved 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
[[Page 32787]]
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 of this document.
Sections 601.12(b)(1) and (b)(3), (c)(1) and (c)(3), and (c)(5),
and (d)(1) and (d)(3) require applicants to follow specific procedures
to submit information to FDA of any changes, in the product, production
process, quality controls, equipment, facilities, or responsible
personnel established in an approved license application. The
appropriate procedure depends on the potential for the change to have a
substantial, moderate, or minimal adverse effect on the identity,
strength, quality, purity, or potency of the products as they may
relate to the safety or effectiveness of the product. Under Sec.
601.12(b)(4), an applicant may ask FDA to expedite its review of a
supplement for public health reasons or if a delay in making the change
described in it would impose an extraordinary hardship of the
applicant. The burden estimate for Sec. 601.12(b) (4) is minimal and
included in the estimate under Sec. 601.12(b)(1) and (b)(3) in table 1
of this document.
Section 601.12(e) requires applicants to submit a protocol, or
change to a protocol, as a supplement requiring FDA approval before
distributing the product. Section 601.12(f)(1), (f)(2), and (f)(3)
requires applicants to follow specific procedures to report certain
labeling changes to FDA. Section 601.12(f)(4) requires applicants to
report to FDA advertising and promotional labeling and any changes.
Under section 601.14, the content of labeling required in Sec.
201.100(d)(3) must be in electronic format and in a form that FDA can
process, review, and archive. This requirement is in addition to the
provisions of Sec. Sec. 601.2(a) and 601.12(f). The burden estimate
for Sec. 601.14 is minimal and included in the estimate under
Sec. Sec. 601.2(a) (BLAs) and 601.12(f)(1), (f)(2), and (f)(3)
(labeling supplements and annual reports) in table 1 of this document.
Section 601.45 requires applicants of biological products for
serious or life-threatening illnesses to submit to the agency for
consideration, during the pre-approval review period, copies of all
promotional materials, including promotional labeling as well as
advertisements.
In addition to Sec. Sec. 601.2 and 601.12, there are other
regulations in 21 CFR parts 640, 660, and 680 that relate to
information to be submitted in a license application or supplement for
certain blood or allergenic products as follows: Sec. Sec. 640.6,
640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c),
640.74(a), and (b)(2), 660.51(a)(4), 680.1(b)(2)(iii), and 680.1(d). In
table 1 of this document, the burden associated with the information
collection requirements in these 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.
640.70(a) for Source Plasma; 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 Sec. 809.10. Therefore, the burden
estimates for these regulations are included in the estimate under
Sec. Sec. 610.60 through 610.65 in table 1 of this document. The
burden estimates associated with Sec. 809.10 are approved under OMB
Control No. 0910-0485.
Section 601.25(b) requests interested persons to submit, for review
and evaluation by an advisory review panel, published and unpublished
data and information pertinent to a designated category of biological
products that have been licensed prior to July 1, 1972. Section
601.26(f) requires that licensees submit to FDA a written statement
intended to show that studies adequate and appropriate to resolve the
questions raised about a biological product have been undertaken for a
product if designated as requiring further study under the
reclassification procedures. Under Sec. 601.25(b), FDA estimates no
PRA burden for this regulation, and therefore this regulation is not
included in table 1 of this document. Under section 601.26(f), FDA
estimates no burden for this regulation since there are no products
designated to require further study and none are predicted in the
future. However, FDA is using an estimate of 1 for calculation
purposes. Based on the possible reclassification of a product, the
labeling for the product may need to be revised, or a manufacturer, on
its own initiative, may deem it necessary for further study. As a
result, any changes to product labeling would be reported under the
appropriate subsection of Sec. 601.12.
Section 601.27(a) requires that applications for new biological
products contain data that are adequate to assess the safety and
effectiveness of the biological product for the claimed indications in
pediatric subpopulations, and to support dosing and administration
information. Section 601.27(b) provides that an applicant may request a
deferred submission of some or all assessments of safety and
effectiveness required under Sec. 601.27(a) until after licensing the
product for use in adults. Section 601.27(c) provides that an applicant
may request a full or partial waiver of the requirements under Sec.
601.27(a) with adequate justification. The burden estimates for Sec.
601.27(a) are included in the burden estimate under Sec. 601.2(a) in
table 1 of this document since these regulations deal with information
to be provided in an application.
Section 601.28 requires sponsors of licensed biological products to
submit the information in Sec. 601.28(a), (b), and (c) to the Center
for Biologics Evaluation and Research (CBER) or 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
then under this section.
[[Page 32788]]
Sections 601.33 through 601.35 clarify the information to be
submitted in an application to FDA to evaluate the safety and
effectiveness of in vivo radiopharmaceuticals. The burden estimates for
Sec. Sec. 601.33 through 601.35 are included in the burden estimate
under Sec. 601.2(a) in table 1 of this document 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 No. 0910-
0001). Under Sec. 601.70(d), two copies of the annual report shall be
submitted to FDA.
Section 601.91 through 601.94 concerns biological products for
which human efficacy studies are not ethical or feasible. Section
601.91(b)(3) requires applicants to prepare and provide labeling with
relevant information to patient or potential patient for biological
products approved under the subpart 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 this subpart are subject to the postmarketing recordkeeping and
safety reporting applicable to all approved biological products.
Section 601.94 requires applicants under this subpart to submit to the
agency for consideration during preapproval review period copies of all
promotional materials including promotional labeling as well as
advertisements.
Under Sec. 601.93, 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 No.
0910-0308). Therefore, any burdens associated with these requirements
would be reported under the AER information collection requirements
(OMB Control No. 0910-0308).
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 of this document.
Section 610.11(g)(2) provides that a manufacturer of certain
biological products may request an exemption from the general safety
test (GST) requirements contained in this subpart. Under Sec.
610.11(g)(2), FDA requires only those manufacturers of biological
products requesting an exemption from the GST to submit additional
information as part of a license application or supplement to an
approved license application. Therefore, the burden estimate for Sec.
610.11(g)(2) is included in the estimate under Sec. Sec. 601.2(a) and
601.12(b) in table 1 of this document.
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. 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 of this document.
Section 680.1(c) requires manufacturers to update annually their
license file with the list of source materials and the suppliers of the
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA
when certain diseases are detected in source materials.
Sections 600.15(b) and 610.53(d) 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) requires the submission
of a request for approval to perform plasmapheresis of donors who do
not meet certain donor requirements for the collection of plasma
containing rare antibodies. Under Sec. Sec. 600.15(b), 610.53(d), and
606.110(b), a request for an exemption or modification to the
requirements would be submitted as a supplement. Therefore, the burden
hours for any submissions under Sec. Sec. 600.15(b), 610.53(d), and
606.110(b) are included in the estimates under Sec. 601.12(b) in table
1 of this document.
In July 1997, FDA revised Form FDA 356h ``Application to Market a
New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize
application procedures between CBER and CDER. The application form
serves primarily as a checklist for firms to gather and submit certain
information to FDA. The checklist 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. 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 No. 0910-0001.
Form FDA 2567 ``Transmittal of Labels and Circulars'' is used by
manufacturers of licensed biological products to submit labeling (e.g.,
circulars, package labels, container labels, etc.) and labeling changes
for FDA review and approval. The labeling information is submitted with
the form for license applications, supplements, or as part of an annual
report. Form FDA 2567 is also used for the transmission of
advertisements and promotional labeling. Form FDA 2567 serves as an
easy guide to assure that the manufacturer has provided the information
required for expeditious handling of their labeling by CBER. For
advertisements and promotional labeling, manufacturers of licensed
biological products may submit to CBER either Form FDA 2567 or 2253.
Form FDA 2253 was previously used only by drug manufacturers regulated
by CDER. In August 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 is approved under
OMB Control No. 0910-0001.
Under table 1 of this document, the number of respondents is 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) 2008. Based on information obtained from FDA's
database systems, there are an estimated 301 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. Based
on previous estimates, the rate of submissions is not expected to
change
[[Page 32789]]
significantly in the next few years. 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.
Under Sec. Sec. 601.12(f)(4) and 601.45, manufacturers of
biological products may use either Form FDA 2567 or Form FDA 2253 to
submit advertising and promotional labeling. Based on information
obtained from FDA's database system, there were an estimated 4,452
submissions of advertising and promotional labeling. FDA estimates that
approximately 15% of those submissions were received with Form FDA 2567
and 85% were received with Form 2253.
Under Sec. Sec. 601.28 and 601.70(b), FDA estimates that it takes
an applicant approximately 24 hours (8 hours per study x 3 studies)
annually to gather, complete, and submit the appropriate information
for each postmarketing status report (approximately two to four studies
per report) and the accompanied transmittal Form FDA 2252. Included in
these 24 hours is the time necessary to prepare and submit two copies
of the annual progress report of postmarketing studies to FDA under
Sec. 601.70(d).
Under Sec. Sec. 601.91 through 601.94, FDA expects to receive very
few applications for these products; however, for calculation purposes,
FDA is estimating the annual submission of one application. Under
Sec. Sec. 601.93(b)(3) and 601.94, FDA estimates 240 hours for a
manufacturer of a new biological product to develop patient labeling,
and to submit the appropriate information and promotional labeling to
FDA. The majority of the burden for developing the patient labeling is
included under the reporting requirements for Sec. 601.94, therefore
minimal burden is calculated for providing the guide to patients under
Sec. 601.91(b)(3).
There were a total of 5,338 amendments to an unapproved application
or supplement and resubmissions submitted using Form FDA 356h.
In the Federal Register of January 26, 2010 (75 FR 4081), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on this
information collection request.
FDA estimates the burden of this collection of information as
follows:
Table 1. -- Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Form FDA No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a)\2\, 610.60 through 610.65\3\ 2567/356h 23 2 46 860 39,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.5(a) NA 11 3 33 20 minutes 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a) NA 1 21 21 20 minutes 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(a)(5) NA 802 9 7,218 1 7,218
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(b)(1)/(b)(3)/(e)\4\ 356h \2\ 166 5 830 80 66,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(c)(1)/(c)(3)\5\ 356h \2\ 141 5 705 50 35,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(c)(5) 356h \2\ 42 5 210 50 10,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(d)(1)/(d)(3)/(f)(3)\7\ 356h \2\ 246 3 738 23 16,974
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(1)\6\ 2567 112 2 224 40 8,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(2)\6\ 2567 53 3 159 20 3,180
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(4)/601.45 2567/2253 42 106 4,452 10 44,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.26(f) NA 1 1 1 1 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.27(b) NA 6 1 6 24 144
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.27(c) NA 10 1 10 8 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.70(b) and (d)/601.28 2252 39 2 78 24 1,872
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.91(b)(3), 601.94 NA 1 1 1 240 240
--------------------------------------------------------------------------------------------------------------------------------------------------------
680.1(c) NA 9 1 9 2 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
680.1(b)(3)(iv) NA 1 1 1 2 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 32790]]
Amendments/Resubmissions 356h 314 17 5,338 20 106,760
--------------------------------------------------------------------------------------------------------------------------------------------------------
TOTAL 341,697
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec. Sec. 610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec. 601.2(a).
\3\ The reporting requirements under Sec. Sec. 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c),
660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under Sec. Sec. 610.60 through 610.65.
\4\ The reporting requirements under Sec. Sec. 610.9(a), 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec. 601.12(b).
\5\ The reporting requirements under Sec. Sec. 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. 601.14 is included in the estimate under Sec. 601.12(f)(1) and (f)(2).
\7\ The reporting requirement under Sec. 601.14 is included in the estimate under Sec. 601.12(f)(3).
Under table 2 of this document, the estimated recordkeeping burden
of 1 hour is based on previous estimates for the recordkeeping
requirements associated with the AER (Adverse Event Reports) system.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Total Annual Hours per
Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
601.91(b)(2) 1 1 1 1 1
(iii)
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13815 Filed 6-8-10; 8:45 am]
BILLING CODE 4160-01-S
