Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567, 64536-64541 [E6-18445]
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64536
Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices
notice. This notice solicits comments on
an information collection to meet
specified requirements for submitting
adequate and well-controlled studies to
provide substantial evidence of
effectiveness for a new animal drug.
DATES: Submit written or electronic
comments on the collection of
information by January 2, 2007.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
1472.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Substantial Evidence of Effectiveness of
New Animal Drug—21 CFR 514.4(a)
(OMB Control Number 0910–0356)—
Extension
Section 512(d)(1)(E) of the Federal
Food Drug and Cosmetic Act (the act)
(21 U.S.C. 360b(d)(1)(E)) requires FDA
to issue an order refusing to approve a
New Animal Drug Application (NADA),
if there is a lack of substantial evidence
that a new animal drug will have the
effect it is purported or represented to
have under the conditions of use
prescribed in the proposed labeling.
Therefore, substantial evidence must be
submitted to us as part of the NADA to
establish effectiveness of a drug. Section
514.4(a) specifies requirements for
submitting adequate and well-controlled
studies to provide substantial evidence
of effectiveness for a new animal drug.
This information collection requirement
provides for submissions of substantial
evidence of effectiveness information
via electronic submissions to the Center
for Veterinary Medicine.
We are continuously seeking ways
through advances in information
technology to reduce the burden on the
government and sponsors. We are
continuing to look at what information
can be submitted electronically and will
permit electronic submission of data to
NADA files as technology and resources
permit.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
514.4(a)
1There
Annual Frequency
per Response
190
Total Annual
Responses
4,546
860
632.6
Total Hours
544,036
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate for the annual reporting
burden for this collection of information
was derived from discussion with
industry and agency records.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18432 Filed 11–1–06; 8:45 am]
[Docket No. 2006N–0430]
BILLING CODE 4160–01–S
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Hours per
Respondent
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions: Biologics License
Application, Changes to an Approved
Application, Labeling, Revocation and
Suspension, Postmarketing Studies
Status Reports, and Forms FDA 356h
and 2567
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
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opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection related to
general licensing provisions for
biologics license applications (BLAs),
changes to an approved application,
labeling, revocation and suspension,
postmarketing studies status reports,
and Forms FDA 356h and 2567.
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices
Submit written or electronic
comments on the collection of
information by January 2, 2007.
DATES:
Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
ADDRESSES:
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.
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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SUPPLEMENTARY INFORMATION:
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General Licensing Provisions: Biologics
License Application, Changes to an
Approved Application, Labeling,
Revocation and Suspension,
Postmarketing Studies Status Reports,
and Forms FDA 356h 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 §§ 610.60, 610.61, and
610.62. 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
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64537
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)
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.
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices
Under § 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)
(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
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. 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).
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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 § 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
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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
then under this section.
Sections 601.33 through 601.35 clarify
the information to be submitted in an
application to FDA to evaluate the
safety and effectiveness of 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)(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) (21 CFR
610.11(g)(2)) provides that a
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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 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
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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
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64539
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 § 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).
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices
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.
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, 610.61,
and 610.623
Form FDA No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
860
24,080
2567/356h
14
2
28
601.5(a)
NA
16
3.13
50
.33
17
601.6(a)
NA
1
21
.33
7
601.12(a)(5)
NA
190
601.12(b)(1)/(b)(3)4
356h2
190
601.12(c)(1)/(c)(35
356h2
601.12(c)(5)
356h2
601.12(d)(1)/(d)(3)
601.12(e)
21
2,983
1
2,983
4.75
903
80
72,240
98
2.60
255
50
12,750
34
1.38
47
50
2,350
356h2
166
1.37
227
22.5
5,107.5
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
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
356h
306
11.6
3,563
20
71,260
601.70(b) and (d)
Amendments/Resubmissions
15.7
Total
33.5
4,824
335,806.5
1There
mstockstill on PROD1PC61 with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2The 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).
3The reporting requirements under §§ 640.70(a), 640.74(b)(3), and (b)(4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) and (b), 660.35(a),
(c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under § 610.60 through 610.62.
4The 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).
5The 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).
6The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2).
7The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3).
Under table 2, the estimated
recordkeeping burden of 1 hour is based
on previous estimates for the
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices
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
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Cellular, Tissue
and Gene Therapies Advisory
Committee.
mstockstill on PROD1PC61 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: October 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–18445 Filed 11–1–06; 8:45 am]
ACTION:
Annual Frequency
per Recordkeeping
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held by teleconference on November 20,
2006, from 2:15 p.m. to approximately
5 p.m.
Location: National Institutes of Health
(NIH), Bldg. 29, rm. 121, 9000 Rockville
Pike, MD. This meeting will be held by
teleconference. The public is welcome
to attend the meeting at the specified
location. A speakerphone will be
provided at the specified location for
public participation in the meeting.
Important information about
transportation, directions to the NIH
campus, parking, and security
procedures is available on the Internet
at https://www.nih.gov/about/visitor/
index.htm. Visitors must show two
forms of identification, one of which
must be a Government-issued photo
identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. If you are
planning to drive to and park on the
NIH campus, you must enter at the
South Dr. entrance of the campus which
is located on Wisconsin Ave. (the
Medical Center Metro entrance), and
allow extra time for vehicle inspection.
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14:49 Nov 01, 2006
Jkt 211001
Detailed information about security
procedures is located at https://
www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking,
visitors are encouraged to use public
transportation. (FDA has verified the
Web site addresses, but FDA is not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
Contact Person: Gail Dapolito or
Rosanna Harvey, Center for Biologics
Evaluation and Research, (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD, 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512389. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On November 20, 2006, the
committee will meet in open session to
hear updates of research programs in the
Laboratory of Immunobiology and the
Laboratory of Immunology, Office of
Biotechnology Products, Center for Drug
Evaluation and Research.
Procedure: On November 20, 2006,
from 2:15 p.m. to approximately 4:30
p.m., the meeting is open to the public.
Interested persons may present data,
information, or views, orally or in
writing, on issues pending before the
committee. Written submissions may be
made to the contact person on or before
November 13, 2006. Oral presentations
from the public will be scheduled
between approximately 3:30 p.m. and
4:30 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 13, 2006.
Closed Committee Deliberations: On
November 20, 2006, from approximately
4:30 p.m. to 5 p.m., the meeting will be
closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
PO 00000
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committee will discuss a report of
intramural research programs.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Gail Dapolito
at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 27, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning
[FR Doc. E6–18472 Filed 11–1–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Oncology Subcommittee of the
Oncologic Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 6, 2006, from 8:30
a.m. to 5 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
E:\FR\FM\02NON1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 212 (Thursday, November 2, 2006)]
[Notices]
[Pages 64536-64541]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18445]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0430]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Licensing Provisions: Biologics License
Application, Changes to an Approved Application, Labeling, Revocation
and Suspension, Postmarketing Studies Status Reports, and Forms FDA
356h and 2567
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
related to general licensing provisions for biologics license
applications (BLAs), changes to an approved application, labeling,
revocation and suspension, postmarketing studies status reports, and
Forms FDA 356h and 2567.
[[Page 64537]]
DATES: Submit written or electronic comments on the collection of
information by January 2, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
General Licensing Provisions: Biologics License Application, Changes to
an Approved Application, Labeling, Revocation and Suspension,
Postmarketing Studies Status Reports, and Forms FDA 356h 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. 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) 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.
[[Page 64538]]
Under Sec. 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.
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. 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
then under this section.
Sections 601.33 through 601.35 clarify the information to be
submitted in an application to FDA to evaluate the safety and
effectiveness of 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)(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) (21 CFR 610.11(g)(2)) provides that a
[[Page 64539]]
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 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 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).
[[Page 64540]]
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.
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, 610.61, and 610.62\3\ 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\ 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (b)(4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) and (b),
660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under 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.
[[Page 64541]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
----------------------------------------------------------------------------------------------------------------
601.91(b)(2)(i 1 1 1 1 1
ii)
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 25, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18445 Filed 11-1-06; 8:45 am]
BILLING CODE 4160-01-S
