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 456h and 2567, 5057-5061 [E7-1741]
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respondents. Each panel member has
provided demographic data for their
household that allows for the selection
of samples that resemble closely the
distribution of the U.S. population on
age, gender, education, and race/
ethnicity. A participant recruitment
questionnaire (screener) will be used to
planned. Testing the statements
experimentally will provide valuable
information on the comprehension,
usefulness, and selection of the side
effect statements to be included in the
final rule.
FDA estimates the burden of this
collection of information as follows:
ensure recruitment criteria are met.
Conventional statistical techniques for
experimental data (such as descriptive
statistics, analysis of variance, and
regression models) will be used to
analyze the data. This proposed data
collection will be one-time only. No
successive related data collections are
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
Administration of Participant Screener
1,684
1
1,684
0.01
17
Administration of Participant Questionnaire
1,600
1
1,600
0.15
240
Total
257
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1674 Filed 2–1–07; 8:45 am]
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
BILLING CODE 4160–01–S
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0430]
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 456h
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 March 5,
2007.
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:
202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
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ADDRESSES:
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General Licensing Provisions: Biologics
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension,
Postmarketing Studies Status Reports,
and Forms FDA 456h and 2567—(OMB
Control Number 0910–0338)—Extension
Under section 351 of the Public
Health Service Act (the PHS Act) (42
U.S.C. 262), manufacturers of biological
products must submit a license
application for FDA review and
approval before marketing a biological
product in interstate commerce.
Licenses may be issued only upon
showing that the establishment and the
products for which a license is desired
meets standards prescribed in
regulations designed to ensure the
continued safety, purity, and potency of
such products. All such licenses are
issued, suspended, and revoked as
prescribed by regulations in part 601 (21
CFR part 601).
Section 130(a) of the Food and Drug
Administration Modernization Act
(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
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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
conducting 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.
Section 601.2(a) requires a
manufacturer of a biological product to
submit an application with
accompanying information, including
labeling information, to FDA for
approval to market a product in
interstate commerce. The container and
package labeling requirements are
provided under §§ 610.60, 610.61, and
610.62 (21 CFR part 610). 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 licensee to submit to FDA notice of its
intention to discontinue manufacture of
a product or all products. Section
601.6(a) requires the licensee to notify
selling agents and distributors upon
suspension of its license, and provide
FDA of such notification.
Section 601.12(a)(2) requires,
generally, that the holder of an
approved BLA must assess the effects of
a manufacturing change before
distributing a biological product made
with the change. Section 601.12(a)(4)
requires, generally, that the applicant
must promptly review all promotional
labeling and advertising to make it
consistent with any labeling changes
implemented. Section 601.12(a)(5)
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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) (Form FDA
2567) in table 1 of this document or
OMB control number 0910–0001
(expires May 31, 2008) since the
required information can also be
submitted with Form FDA 2253.
Section 601.12(b)(1) and (b)(3), (c)(1)
and (c)(3), (c)(5), and (d)(1) and (d)(3)
require applicants to follow specific
procedures to inform FDA of each
change, in the product, production
process, quality controls, equipment,
facilities, responsible personnel or
labeling 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 labeling
changes to FDA. Section 601.12(f)(4)
requires applicants to report to FDA
advertising and promotional labeling
and any changes.
Under § 601.14, the content of
labeling required in § 201.100(d)(3) (21
CFR 201.100(d)(3)) must be in electronic
format and in a form that FDA can
process, review, and archive. This
requirement is in addition to the
provisions of §§ 601.2(a) and 601.12(f).
The burden estimate for § 601.14 is
minimal and included in the estimate
under § 601.2(a) (BLAs) and 601.12(f)(1),
(f)(2), and (f)(3) (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 parts 640,
660, and 680 (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: §§ 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 section 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:
§ 640.70(a) for Source Plasma;
§ 640.74(b)(3) and (b)(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)
and (b) 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
§ 610.62 or § 809.10 (21 CFR 809.10).
Therefore, the burden estimates for
these regulations are included in the
estimate under § 610.60 through
§ 610.62 in table 1 of this document.
The burden estimates associated with
§ 809.10 are approved under OMB
control number 0910–0485 (expires June
30, 2008).
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) requests that licensees
submit to FDA a written statement
intended to show that studies adequate
and appropriate to resolve questions
raised about a biological product have
been undertaken for a product if
designated as requiring further study
under the reclassification procedures.
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Under § 601.25(b)(3), FDA estimates no
burden for this regulation since all
requested data and information had
been submitted by 1974. Under
§ 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, 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 § 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).
Section 601.27(c) provides that an
applicant may request a full or partial
waiver of the requirements under
§ 601.27(a). 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 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, or
on behalf of, the applicant. If the
postmarketing studies were required or
agreed to, the status of these studies is
to be reported under § 601.70, rather
than under this section.
Sections 601.33 through 601.35 clarify
the information to be submitted in an
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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
(approved under OMB control number
0910–0001). Under § 601.70(d), two
copies of the annual report shall be
submitted to FDA.
Section 601.91(b)(2)(iii) requires, in
certain circumstances, postmarketing
restrictions as needed to ensure the safe
use of the biological products
distribution conditioned on specified
recordkeeping requirements. 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 number
0910–0308; expires May 31, 2005).
Therefore, any burdens associated with
these requirements would be reported
under the AER information collection
requirements (OMB control number
0910–0308).
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
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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 610.67 requires certain
biological products to comply with the
bar code requirements at § 201.25 (21
CFR 201.25). Section 201.25 is approved
under OMB control number 0910–0537
(expires February 28, 2007).
Section 680.1(c) requires
manufacturers to update annually their
license file with the list of source
materials and the suppliers of the
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
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 submissions
to CDER using Form FDA 356h are
reported under OMB control number
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
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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 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.
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.
Based on information obtained from
FDA’s database systems, there are an
estimated 306 licensed biologics
manufacturers. However, not all
manufacturers will have any
submissions in a given year and some
may have multiple submissions. 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 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 as follows 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
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and a complex application or
supplement.
Under § 601.6(a), the total annual
responses are based on FDA estimates
that establishments may notify an
average of 20 selling agents and
distributors of such suspension, and
provide FDA of such notification. The
number of respondents is based on the
estimated annual number of
suspensions of a biologic license.
Under §§ 601.12(f)(4) and 601.45,
manufacturers of biological products
may use either Form FDA 2567 or Form
FDA 2253 to submit advertising and
promotional labeling. Based on
information obtained from FDA’s
database system, there were an
estimated 3,600 submissions of
advertising and promotional labeling in
fiscal year 2004. FDA estimates that
approximately 15 percent of those
submissions were received with Form
FDA 2567 resulting in an estimated 540
submissions. The burden hours for the
remaining submissions received using
Form FDA 2253 are reported under
OMB control number 0910–0001.
Under § 601.70(b), FDA estimates that
it takes an applicant approximately 24
hours (8 hours per study x 3) 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 of this
nature; 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 also 3,540 amendments to
an unapproved application or
supplement and 23 resubmissions (total
of 3,563 submissions) submitted using
Form FDA 356h.
In the Federal Register of November
2, 2006 (71 FR 64536), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
Form FDA No.
601.2(a)2, 610.60, 610.61,
and 610.623
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
2567/356h
14
2
28
860
24,080
601.5(a)
NA
16
3.13
50
.33
17
601.6(a)
NA
1
21
21
.33
7
601.12(a)(5)
NA
190
15.7
2,983
1
2,983
601.12(b)(1)/(b)(3)4
356h2
190
4.75
903
80
72,240
601.12(c)(1)/(c)(3)5
356h2
98
2.60
255
50
12,750
601.12(c)(5)
356h2
34
1.38
47
50
2,350
601.12(d)(1)/(d)(3)
356h2
166
1.37
227
22.5
5,107.5
601.12(e)
356h2
14
1.43
20
120
2,400
601.12(f)(1)6
2567
12
1
12
40
480
601.12(f)(2)6
2567
10
1
10
20
200
601.12(f)(3)7
2567
70
1.43
100
10
1,000
601.12(f)(4)/601.45
2567
15
36
540
10
5,400
601.25(b)(3)
NA
0
0
0
0
0
601.26(f)
NA
0
0
0
0
0
601.27(b)
NA
3
1
3
24
72
601.27(c)
NA
7
1
7
8
56
601.28(a), (b), and (c)
NA
44
3.27
144
33.5
4,824
2252
19
1.58
30
24
720
601.91(b)(3), 601.94
NA
1
1
1
240
240
610.67
NA
174
31
5,400
24
129,600
680.1(c)
NA
10
1
10
2
20
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TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
21 CFR Section
No. of
Respondents
Form FDA No.
Amendments/Resubmissions
356h
Annual Frequency per
Response
306
Total Annual
Responses
11.6
Hours per
Response
3,563
Total Hours
20
Total
71,260
335,806.5
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, 610.11(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) and (b), 660.35(a), (cg), and (i-m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.62.
4 The reporting requirements under §§ 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), and 680.1(d) are included in the estimate under § 601.12(b)
5 The reporting requirements under §§ 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, the estimated
recordkeeping burden of 1 hour is based
on previous estimates for the
recordkeeping requirements associated
with the AER system.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
601.91(b)(2)(iii)
1There
1
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0052]
Determination That SUSTIVA
(Efavirenz) 300-Milligram Tablets Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
sroberts on PROD1PC70 with NOTICES
Total Annual
Records
1
Hours per
Record
1
Total Hours
1
1
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1741 Filed 2–1–07; 8:45 am]
ACTION:
Annual Frequency per
Recordkeeping
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
that SUSTIVA (efavirenz) 300-milligram
(mg) tablets were not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for efavirenz
300-mg tablets, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
VerDate Aug<31>2005
16:13 Feb 01, 2007
Jkt 211001
Lane, Rockville, MD 20857, 301–594–
2041.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors must, with certain exceptions,
show that the drug for which they are
seeking approval contains the same
active ingredient in the same strength
and dosage form as the ‘‘listed drug,’’
which is typically a version of the drug
that was previously approved under a
new drug application (NDA). Sponsors
of ANDAs do not have to repeat the
extensive clinical testing otherwise
necessary to gain approval of an NDA.
The only clinical data required in an
ANDA are data to show that the drug
that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn from the list if the
agency withdraws or suspends approval
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
of the drug’s NDA or ANDA for reasons
of safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
ANDA that does not refer to a listed
drug.
In a citizen petition dated January 24,
2006 (Docket No. 2006P–0052/CP1),
submitted under 21 CFR 10.30, Robert
W. Pollock of Lachman Consultant
Services, Inc., requested that the agency
determine whether SUSTIVA (efavirenz)
300-mg tablets were withdrawn from
sale for reasons of safety or
effectiveness. SUSTIVA (efavirenz) is
approved for the treatment of human
immunodeficiency virus (HIV) type 1
infections in combination with other
antiretroviral agents. SUSTIVA
(efavirenz) 300-mg tablets are the
subject of NDA 21–360 held by BristolMyers Squibb Pharma Company (BMS).
FDA approved the NDA for SUSTIVA
(efavirenz) 300-mg tablets on February
1, 2002.
After considering the citizen petition
and reviewing agency records, FDA has
determined that SUSTIVA (efavirenz)
E:\FR\FM\02FEN1.SGM
02FEN1
]]>Agencies
[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5057-5061]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1741]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0430]
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 456h 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 March
5, 2007.
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: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
General Licensing Provisions: Biologics License Application, Changes to
an Approved Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Forms FDA 456h and 2567--(OMB
Control Number 0910-0338)--Extension
Under section 351 of the Public Health Service Act (the PHS Act)
(42 U.S.C. 262), manufacturers of biological products must submit a
license application for FDA review and approval before marketing a
biological product in interstate commerce. Licenses may be issued only
upon showing that the establishment and the products for which a
license is desired meets standards prescribed in regulations designed
to ensure the continued safety, purity, and potency of such products.
All such licenses are issued, suspended, and revoked as prescribed by
regulations in part 601 (21 CFR part 601).
Section 130(a) of the Food and Drug Administration Modernization
Act (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
conducting 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.
Section 601.2(a) requires a manufacturer of a biological product to
submit an application with accompanying information, including 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, 610.61, and 610.62 (21 CFR part 610). 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
licensee to submit to FDA notice of its intention to discontinue
manufacture of a product or all products. Section 601.6(a) requires the
licensee to notify selling agents and distributors upon suspension of
its license, and provide FDA of such notification.
Section 601.12(a)(2) requires, generally, that the holder of an
approved BLA must assess the effects of a manufacturing change before
distributing a biological product made with the change. Section
601.12(a)(4) requires, generally, that the applicant must promptly
review all promotional labeling and advertising to make it consistent
with any labeling changes implemented. Section 601.12(a)(5)
[[Page 5058]]
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.
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) (Form FDA 2567) in table 1 of this document or OMB control
number 0910-0001 (expires May 31, 2008) since the required information
can also be submitted with Form FDA 2253.
Section 601.12(b)(1) and (b)(3), (c)(1) and (c)(3), (c)(5), and
(d)(1) and (d)(3) require applicants to follow specific procedures to
inform FDA of each change, in the product, production process, quality
controls, equipment, facilities, responsible personnel or labeling
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 labeling
changes to FDA. Section 601.12(f)(4) requires applicants to report to
FDA advertising and promotional labeling and any changes.
Under Sec. 601.14, the content of labeling required in Sec.
201.100(d)(3) (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. 601.2(a) (BLAs) and 601.12(f)(1), (f)(2), and
(f)(3) (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 parts 640, 660, and 680 (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: 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. 601.2 and/or Sec. 601.12. A regulation may be
listed under more than one section 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: Sec. 640.70(a)
for Source Plasma; Sec. 640.74(b)(3) and (b)(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) and (b) 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. 610.60 through Sec. 610.62 or Sec. 809.10 (21 CFR 809.10).
Therefore, the burden estimates for these regulations are included in
the estimate under Sec. 610.60 through Sec. 610.62 in table 1 of this
document. The burden estimates associated with Sec. 809.10 are
approved under OMB control number 0910-0485 (expires June 30, 2008).
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) requests that licensees submit to FDA a written statement
intended to show that studies adequate and appropriate to resolve
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)(3), FDA estimates no
burden for this regulation since all requested data and information had
been submitted by 1974. Under Sec. 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, 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 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). Section 601.27(c)
provides that an applicant may request a full or partial waiver of the
requirements under Sec. 601.27(a). 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 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, or on behalf of, the
applicant. If the postmarketing studies were required or agreed to, the
status of these studies is to be reported under Sec. 601.70, rather
than under this section.
Sections 601.33 through 601.35 clarify the information to be
submitted in an
[[Page 5059]]
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 (approved under OMB control number 0910-
0001). Under Sec. 601.70(d), two copies of the annual report shall be
submitted to FDA.
Section 601.91(b)(2)(iii) requires, in certain circumstances,
postmarketing restrictions as needed to ensure the safe use of the
biological products distribution conditioned on specified recordkeeping
requirements. 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 number 0910-0308; expires May 31,
2005). Therefore, any burdens associated with these requirements would
be reported under the AER information collection requirements (OMB
control number 0910-0308).
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 610.67 requires certain biological products to comply with
the bar code requirements at Sec. 201.25 (21 CFR 201.25). Section
201.25 is approved under OMB control number 0910-0537 (expires February
28, 2007).
Section 680.1(c) requires manufacturers to update annually their
license file with the list of source materials and the suppliers of the
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
submissions to CDER using Form FDA 356h are reported under OMB control
number 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 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.
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.
Based on information obtained from FDA's database systems, there are an
estimated 306 licensed biologics manufacturers. However, not all
manufacturers will have any submissions in a given year and some may
have multiple submissions. 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 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 as follows 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
[[Page 5060]]
and a complex application or supplement.
Under Sec. 601.6(a), the total annual responses are based on FDA
estimates that establishments may notify an average of 20 selling
agents and distributors of such suspension, and provide FDA of such
notification. The number of respondents is based on the estimated
annual number of suspensions of a biologic license.
Under Sec. Sec. 601.12(f)(4) and 601.45, manufacturers of
biological products may use either Form FDA 2567 or Form FDA 2253 to
submit advertising and promotional labeling. Based on information
obtained from FDA's database system, there were an estimated 3,600
submissions of advertising and promotional labeling in fiscal year
2004. FDA estimates that approximately 15 percent of those submissions
were received with Form FDA 2567 resulting in an estimated 540
submissions. The burden hours for the remaining submissions received
using Form FDA 2253 are reported under OMB control number 0910-0001.
Under Sec. 601.70(b), FDA estimates that it takes an applicant
approximately 24 hours (8 hours per study x 3) 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 of this nature; 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 also 3,540 amendments to an unapproved application or
supplement and 23 resubmissions (total of 3,563 submissions) submitted
using Form FDA 356h.
In the Federal Register of November 2, 2006 (71 FR 64536), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Form FDA No. Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a)\2\, 610.60, 610.61, and 2567/356h 14 2 28 860 24,080
610.62\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.5(a) NA 16 3.13 50 .33 17
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a) NA 1 21 21 .33 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(a)(5) NA 190 15.7 2,983 1 2,983
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(b)(1)/(b)(3)\4\ 356h\2\ 190 4.75 903 80 72,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(c)(1)/(c)(3)\5\ 356h\2\ 98 2.60 255 50 12,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(c)(5) 356h\2\ 34 1.38 47 50 2,350
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(d)(1)/(d)(3) 356h\2\ 166 1.37 227 22.5 5,107.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(e) 356h\2\ 14 1.43 20 120 2,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(1)\6\ 2567 12 1 12 40 480
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(2)\6\ 2567 10 1 10 20 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(3)\7\ 2567 70 1.43 100 10 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(4)/601.45 2567 15 36 540 10 5,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.25(b)(3) NA 0 0 0 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.26(f) NA 0 0 0 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.27(b) NA 3 1 3 24 72
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.27(c) NA 7 1 7 8 56
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.28(a), (b), and (c) NA 44 3.27 144 33.5 4,824
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.70(b) and (d) 2252 19 1.58 30 24 720
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.91(b)(3), 601.94 NA 1 1 1 240 240
--------------------------------------------------------------------------------------------------------------------------------------------------------
610.67 NA 174 31 5,400 24 129,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
680.1(c) NA 10 1 10 2 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 5061]]
Amendments/Resubmissions 356h 306 11.6 3,563 20 71,260
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total ............... .................. ..................... .................. ............... 335,806.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, 610.11(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) and (b), 660.35(a),
(c-g), and (i-m), 660.45, and 660.55(a) and (b) are included under Sec. Sec. 610.60 through 610.62.
\4\ The reporting requirements under Sec. Sec. 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), and 680.1(d) are included in the estimate under Sec. 601.12(b)
\5\ The reporting requirements under Sec. Sec. 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, the estimated recordkeeping burden of 1 hour is
based on previous estimates for the recordkeeping requirements
associated with the AER system.
Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Record Total Hours
----------------------------------------------------------------------------------------------------------------
601.91(b)(2)(ii 1 1 1 1 1
i)
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1741 Filed 2-1-07; 8:45 am]
BILLING CODE 4160-01-S
