[Federal Register Volume 72, Number 22 (Friday, February 2, 2007)]
[Notices]
[Pages 5057-5061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1741]


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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.

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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\
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                                                               No. of         Annual Frequency per     Total Annual        Hours per
            21 CFR Section                Form FDA No.       Respondents            Response             Responses          Response       Total Hours
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601.2(a)\2\, 610.60, 610.61, and             2567/356h                  14                      2                  28              860           24,080
 610.62\3\
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601.5(a)                                            NA                  16                   3.13                  50              .33               17
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601.6(a)                                            NA                   1                     21                  21              .33                7
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601.12(a)(5)                                        NA                 190                   15.7               2,983                1            2,983
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601.12(b)(1)/(b)(3)\4\                         356h\2\                 190                   4.75                 903               80           72,240
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601.12(c)(1)/(c)(3)\5\                         356h\2\                  98                   2.60                 255               50           12,750
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601.12(c)(5)                                   356h\2\                  34                   1.38                  47               50            2,350
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601.12(d)(1)/(d)(3)                            356h\2\                 166                   1.37                 227             22.5          5,107.5
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601.12(e)                                      356h\2\                  14                   1.43                  20              120            2,400
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601.12(f)(1)\6\                                   2567                  12                      1                  12               40              480
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601.12(f)(2)\6\                                   2567                  10                      1                  10               20              200
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601.12(f)(3)\7\                                   2567                  70                   1.43                 100               10            1,000
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601.12(f)(4)/601.45                               2567                  15                     36                 540               10            5,400
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601.25(b)(3)                                        NA                   0                      0                   0                0                0
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601.26(f)                                           NA                   0                      0                   0                0                0
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601.27(b)                                           NA                   3                      1                   3               24               72
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601.27(c)                                           NA                   7                      1                   7                8               56
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601.28(a), (b), and (c)                             NA                  44                   3.27                 144             33.5            4,824
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601.70(b) and (d)                                 2252                  19                   1.58                  30               24              720
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601.91(b)(3), 601.94                                NA                   1                      1                   1              240              240
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610.67                                              NA                 174                     31               5,400               24          129,600
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680.1(c)                                            NA                  10                      1                  10                2               20
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[[Page 5061]]

 
Amendments/Resubmissions                          356h                 306                   11.6               3,563               20           71,260
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Total                                   ...............  ..................  .....................  ..................  ...............       335,806.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec.  Sec.   601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(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)
----------------------------------------------------------------------------------------------------------------
\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