
[Federal Register: June 9, 2010 (Volume 75, Number 110)]
[Notices]               
[Page 32786-32790]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn10-68]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0019]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; General Licensing 
Provisions: Biologics License Application, Changes to an Approved 
Application, Labeling, Revocation and Suspension, Postmarketing Studies 
Status Reports, and Forms FDA 356h and 2567

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 July 9, 
2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0338. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Agency Information Collection Activities; Submission for Office of 
Management and Budget Review; Comment Request; General Licensing 
Provisions: Biologics License Application, Changes to an Approved 
Application, Labeling, Revocation and Suspension, Postmarketing Studies 
Status Reports, and Forms FDA 356h and 2567 (OMB Control Number 0910-
0338)--Extension

    Under Section 351 of the Public Health Services Act (the PHS Act) 
(42 U.S.C. 262), manufacturers of biological products must submit a 
license application for FDA review and approval before marketing a 
biological product in interstate commerce. Licenses may be issued only 
upon showing that the establishment and the products for which a 
license is desired meets standards prescribed in regulations designed 
to ensure the continued safety, purity, and potency of such products. 
All such licenses are issued, suspended, and revoked as prescribed by 
regulations in part 601 (21 CFR Part 601).
    Section 130(a) of the Food and Drug Administration Modernization 
Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic 
Act (the act) by adding a new provision (section 506B of the act (21 
U.S.C. 356b)) requiring reports of postmarketing studies for approved 
human drugs and licensed biological products. Section 506B of the act 
provides FDA with additional authority to monitor the progress of 
postmarketing studies that applicants have made a commitment to conduct 
and requires the agency to make publicly available information that 
pertains to the status of these studies. Under section 506B(a) of the 
act, applicants that have committed to conduct a postmarketing study 
for an approved human drug or licensed biological product must submit 
to FDA a status report of the progress of the study or the reasons for 
the failure of the applicant to conduct the study. This report must be 
submitted within 1 year after the U.S. approval of the application and 
then annually until the study is completed or terminated.
    A summary of additional collection of information requirements 
follows.
    Section 601.2(a) requires a manufacturer of a biological product to 
submit an application on forms prescribed for such purposes with 
accompanying data and information, including certain labeling 
information, to FDA for approval to market a product in interstate 
commerce. The container and package labeling requirements are provided 
under Sec. Sec.  610.60 through 610.65. The estimate for these 
regulations is included in the estimate under Sec.  601.2(a) in table 1 
of this document.
    Section 601.5(a) requires a manufacturer to submit to FDA notice of 
its intention to discontinue manufacture of a product or all products. 
Section 601.6(a) requires the manufacturer to notify selling agents and 
distributors upon suspension of its license, and provide FDA of such 
notification.
    Section 601.12 (a)(2) requires, generally, that the holder of an 
approved BLA must assess the effects of a manufacturing change before 
distributing a biological product made with the change. Section 
601.12(a)(4) requires, generally, that the applicant

[[Page 32787]]

must promptly revise all promotional labeling and advertising to make 
it consistent with any labeling changes implemented. Section 
601.12(a)(5) requires the applicant to include a list of all changes 
contained in the supplement or annual report; for supplements, this 
list must be provided in the cover letter. The burden estimates for 
Sec.  601.12(a)(2) are included in the estimates for supplements 
(Sec. Sec.  601.12(b) and (c)) and annual reports (Sec.  601.12(d)). 
The burden estimates for Sec.  601.12(a)(4) are included in the 
estimates under 601.12(f)(4) in table 1 of this document.
    Sections 601.12(b)(1) and (b)(3), (c)(1) and (c)(3), and (c)(5), 
and (d)(1) and (d)(3) require applicants to follow specific procedures 
to submit information to FDA of any changes, in the product, production 
process, quality controls, equipment, facilities, or responsible 
personnel established in an approved license application. The 
appropriate procedure depends on the potential for the change to have a 
substantial, moderate, or minimal adverse effect on the identity, 
strength, quality, purity, or potency of the products as they may 
relate to the safety or effectiveness of the product. Under Sec.  
601.12(b)(4), an applicant may ask FDA to expedite its review of a 
supplement for public health reasons or if a delay in making the change 
described in it would impose an extraordinary hardship of the 
applicant. The burden estimate for Sec.  601.12(b) (4) is minimal and 
included in the estimate under Sec.  601.12(b)(1) and (b)(3) in table 1 
of this document.
    Section 601.12(e) requires applicants to submit a protocol, or 
change to a protocol, as a supplement requiring FDA approval before 
distributing the product. Section 601.12(f)(1), (f)(2), and (f)(3) 
requires applicants to follow specific procedures to report certain 
labeling changes to FDA. Section 601.12(f)(4) requires applicants to 
report to FDA advertising and promotional labeling and any changes.
    Under section 601.14, the content of labeling required in Sec.  
201.100(d)(3) must be in electronic format and in a form that FDA can 
process, review, and archive. This requirement is in addition to the 
provisions of Sec. Sec.  601.2(a) and 601.12(f). The burden estimate 
for Sec.  601.14 is minimal and included in the estimate under 
Sec. Sec.  601.2(a) (BLAs) and 601.12(f)(1), (f)(2), and (f)(3) 
(labeling supplements and annual reports) in table 1 of this document.
    Section 601.45 requires applicants of biological products for 
serious or life-threatening illnesses to submit to the agency for 
consideration, during the pre-approval review period, copies of all 
promotional materials, including promotional labeling as well as 
advertisements.
    In addition to Sec. Sec.  601.2 and 601.12, there are other 
regulations in 21 CFR parts 640, 660, and 680 that relate to 
information to be submitted in a license application or supplement for 
certain blood or allergenic products as follows: Sec. Sec.  640.6, 
640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c), 640.64(c), 
640.74(a), and (b)(2), 660.51(a)(4), 680.1(b)(2)(iii), and 680.1(d). In 
table 1 of this document, the burden associated with the information 
collection requirements in these regulations is included in the burden 
estimate for Sec. Sec.  601.2 and/or 601.12. A regulation may be listed 
under more than one subsection of Sec.  601.12 due to the type of 
category under which a change to an approved application may be 
submitted.
    There are also additional container and/or package labeling 
requirements for certain licensed biological products including: Sec.  
640.70(a) for Source Plasma; Sec.  640.74(b)(3) and (4) for Source 
Plasma Liquid; Sec.  640.84(a) and (c) for Albumin; Sec.  640.94(a) for 
Plasma Protein Fraction; Sec.  660.2(c) for Antibody to Hepatitis B 
Surface Antigen; Sec.  660.28(a), (b), and (c) for Blood Grouping 
Reagent; Sec.  660.35(a), (c through g), and (i through m) for Reagent 
Red Blood Cells; Sec.  660.45 for Hepatitis B Surface Antigen; and 
Sec.  660.55(a) and (b) for Anti-Human Globulin. The burden associated 
with the additional labeling requirements for submission of a license 
application for these certain biological products is minimal because 
the majority of the burden is associated with the requirements under 
Sec. Sec.  610.60 through 610.65 or Sec.  809.10. Therefore, the burden 
estimates for these regulations are included in the estimate under 
Sec. Sec.  610.60 through 610.65 in table 1 of this document. The 
burden estimates associated with Sec.  809.10 are approved under OMB 
Control No. 0910-0485.
    Section 601.25(b) requests interested persons to submit, for review 
and evaluation by an advisory review panel, published and unpublished 
data and information pertinent to a designated category of biological 
products that have been licensed prior to July 1, 1972. Section 
601.26(f) requires that licensees submit to FDA a written statement 
intended to show that studies adequate and appropriate to resolve the 
questions raised about a biological product have been undertaken for a 
product if designated as requiring further study under the 
reclassification procedures. Under Sec.  601.25(b), FDA estimates no 
PRA burden for this regulation, and therefore this regulation is not 
included in table 1 of this document. Under section 601.26(f), FDA 
estimates no burden for this regulation since there are no products 
designated to require further study and none are predicted in the 
future. However, FDA is using an estimate of 1 for calculation 
purposes. Based on the possible reclassification of a product, the 
labeling for the product may need to be revised, or a manufacturer, on 
its own initiative, may deem it necessary for further study. As a 
result, any changes to product labeling would be reported under the 
appropriate subsection of Sec.  601.12.
    Section 601.27(a) requires that applications for new biological 
products contain data that are adequate to assess the safety and 
effectiveness of the biological product for the claimed indications in 
pediatric subpopulations, and to support dosing and administration 
information. Section 601.27(b) provides that an applicant may request a 
deferred submission of some or all assessments of safety and 
effectiveness required under Sec.  601.27(a) until after licensing the 
product for use in adults. Section 601.27(c) provides that an applicant 
may request a full or partial waiver of the requirements under Sec.  
601.27(a) with adequate justification. The burden estimates for Sec.  
601.27(a) are included in the burden estimate under Sec.  601.2(a) in 
table 1 of this document since these regulations deal with information 
to be provided in an application.
    Section 601.28 requires sponsors of licensed biological products to 
submit the information in Sec.  601.28(a), (b), and (c) to the Center 
for Biologics Evaluation and Research (CBER) or Center for Drug 
Evaluation and Research (CDER) each year, within 60 days of the 
anniversary date of approval of the license. Section 601.28(a) requires 
sponsors to submit to FDA a brief summary stating whether labeling 
supplements for pediatric use have been submitted and whether new 
studies in the pediatric population to support appropriate labeling for 
the pediatric population have been initiated. Section 601.28(b) 
requires sponsors to submit to FDA an analysis of available safety and 
efficacy data in the pediatric population and changes proposed in the 
labeling based on this information. Section 601.28(c) requires sponsors 
to submit to FDA a statement on the current status of any postmarketing 
studies in the pediatric population performed by, on or behalf of, the 
applicant. If the postmarketing studies were required or agreed to, the 
status of these studies is to be reported under Sec.  601.70 rather 
then under this section.

[[Page 32788]]

    Sections 601.33 through 601.35 clarify the information to be 
submitted in an application to FDA to evaluate the safety and 
effectiveness of in vivo radiopharmaceuticals. The burden estimates for 
Sec. Sec.  601.33 through 601.35 are included in the burden estimate 
under Sec.  601.2(a) in table 1 of this document since these 
regulations deal with information to be provided in an application.
    Section 601.70 (b) requires each applicant of a licensed biological 
product to submit annually a report to FDA on the status of 
postmarketing studies for each approved product application. Each 
annual postmarketing status report must be accompanied by a completed 
transmittal Form FDA 2252 (Form FDA 2252 approved under OMB No. 0910-
0001). Under Sec.  601.70(d), two copies of the annual report shall be 
submitted to FDA.
    Section 601.91 through 601.94 concerns biological products for 
which human efficacy studies are not ethical or feasible. Section 
601.91(b)(3) requires applicants to prepare and provide labeling with 
relevant information to patient or potential patient for biological 
products approved under the subpart when human efficacy studies are not 
ethical or feasible (or based on evidence of effectiveness from studies 
in animals). Section 601.93 provides that biological products approved 
under this subpart are subject to the postmarketing recordkeeping and 
safety reporting applicable to all approved biological products. 
Section 601.94 requires applicants under this subpart to submit to the 
agency for consideration during preapproval review period copies of all 
promotional materials including promotional labeling as well as 
advertisements.
    Under Sec.  601.93, any potential postmarketing reports and/or 
recordkeeping burdens would be included under the adverse experience 
reporting (AER) requirements under 21 CFR part 600 (OMB Control No. 
0910-0308). Therefore, any burdens associated with these requirements 
would be reported under the AER information collection requirements 
(OMB Control No. 0910-0308).
    Section 610.9(a) requires the applicant to present certain 
information, in the form of a license application or supplement to the 
application, for a modification of any particular test method or 
manufacturing process or the conditions which it is conducted under the 
biologics regulations. The burden estimate for Sec.  610.9(a) is 
included in the estimate under Sec. Sec.  601.2(a) and 601.12(b) and 
(c) in table 1 of this document.
    Section 610.11(g)(2) provides that a manufacturer of certain 
biological products may request an exemption from the general safety 
test (GST) requirements contained in this subpart. Under Sec.  
610.11(g)(2), FDA requires only those manufacturers of biological 
products requesting an exemption from the GST to submit additional 
information as part of a license application or supplement to an 
approved license application. Therefore, the burden estimate for Sec.  
610.11(g)(2) is included in the estimate under Sec. Sec.  601.2(a) and 
601.12(b) in table 1 of this document.
    Section 640.120 requires licensed establishments to submit a 
request for an exception or alternative to any requirement in the 
biologics regulations regarding blood, blood components, or blood 
products. A request for an exception or alternative must be submitted 
in accordance with Sec.  601.12; therefore the burden estimate for 
Sec.  640.120 is included in the estimate under Sec.  601.12(b) in 
table 1 of this document.
    Section 680.1(c) requires manufacturers to update annually their 
license file with the list of source materials and the suppliers of the 
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA 
when certain diseases are detected in source materials.
    Sections 600.15(b) and 610.53(d) require the submission of a 
request for an exemption or modification regarding the temperature 
requirements during shipment and from dating periods, respectively, for 
certain biological products. Section 606.110(b) requires the submission 
of a request for approval to perform plasmapheresis of donors who do 
not meet certain donor requirements for the collection of plasma 
containing rare antibodies. Under Sec. Sec.  600.15(b), 610.53(d), and 
606.110(b), a request for an exemption or modification to the 
requirements would be submitted as a supplement. Therefore, the burden 
hours for any submissions under Sec. Sec.  600.15(b), 610.53(d), and 
606.110(b) are included in the estimates under Sec.  601.12(b) in table 
1 of this document.
    In July 1997, FDA revised Form FDA 356h ``Application to Market a 
New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize 
application procedures between CBER and CDER. The application form 
serves primarily as a checklist for firms to gather and submit certain 
information to FDA. The checklist helps to ensure that the application 
is complete and contains all the necessary information, so that delays 
due to lack of information may be eliminated. The form provides key 
information to FDA for efficient handling and distribution to the 
appropriate staff for review. The estimated burden hours for 
nonbiological product submissions to CDER using FDA Form 356h are 
approved under OMB Control No. 0910-0001.
    Form FDA 2567 ``Transmittal of Labels and Circulars'' is used by 
manufacturers of licensed biological products to submit labeling (e.g., 
circulars, package labels, container labels, etc.) and labeling changes 
for FDA review and approval. The labeling information is submitted with 
the form for license applications, supplements, or as part of an annual 
report. Form FDA 2567 is also used for the transmission of 
advertisements and promotional labeling. Form FDA 2567 serves as an 
easy guide to assure that the manufacturer has provided the information 
required for expeditious handling of their labeling by CBER. For 
advertisements and promotional labeling, manufacturers of licensed 
biological products may submit to CBER either Form FDA 2567 or 2253. 
Form FDA 2253 was previously used only by drug manufacturers regulated 
by CDER. In August of 1998, FDA revised and harmonized Form FDA 2253 so 
the form may be used to transmit specimens of promotional labeling and 
advertisements for biological products as well as for prescription 
drugs and antibiotics. The revised, harmonized form updates the 
information about the types of promotional materials and the codes that 
are used to clarify the type of advertisement or labeling submitted; 
clarifies the intended audience for the advertisements or promotional 
labeling (e.g., consumers, professionals, news services); and helps 
ensure that the submission is complete. Form FDA 2253 is approved under 
OMB Control No. 0910-0001.
    Under table 1 of this document, the number of respondents is based 
on the estimated annual number of manufacturers that submitted the 
required information to FDA or the number of submissions FDA received 
in fiscal year (FY) 2008. Based on information obtained from FDA's 
database systems, there are an estimated 301 licensed biologics 
manufacturers. The total annual responses are based on the estimated 
number of submissions (i.e., license applications, labeling and other 
supplements, protocols, advertising and promotional labeling, 
notifications) for a particular product received annually by FDA. Based 
on previous estimates, the rate of submissions is not expected to 
change

[[Page 32789]]

significantly in the next few years. The hours per response are based 
on information provided by industry and past FDA experience with the 
various submissions or notifications. The hours per response include 
the time estimated to prepare the various submissions or notifications 
to FDA, and, as applicable, the time required to fill out the 
appropriate form and collate the documentation. Additional information 
regarding these estimates is provided below as necessary.
    Under Sec. Sec.  601.2 and 601.12, the estimated hours per response 
are based on the average number of hours to submit the various 
submissions. The estimated average number of hours is based on the 
range of hours to complete a very basic application or supplement and a 
complex application or supplement.
    Under section 601.6(a), the total annual responses are based on FDA 
estimates that establishments may notify an average of 20 selling 
agents and distributors of such suspension, and provide FDA of such 
notification. The number of respondents is based on the estimated 
annual number of suspensions of a biologic license.
    Under Sec. Sec.  601.12(f)(4) and 601.45, manufacturers of 
biological products may use either Form FDA 2567 or Form FDA 2253 to 
submit advertising and promotional labeling. Based on information 
obtained from FDA's database system, there were an estimated 4,452 
submissions of advertising and promotional labeling. FDA estimates that 
approximately 15% of those submissions were received with Form FDA 2567 
and 85% were received with Form 2253.
    Under Sec. Sec.  601.28 and 601.70(b), FDA estimates that it takes 
an applicant approximately 24 hours (8 hours per study x 3 studies) 
annually to gather, complete, and submit the appropriate information 
for each postmarketing status report (approximately two to four studies 
per report) and the accompanied transmittal Form FDA 2252. Included in 
these 24 hours is the time necessary to prepare and submit two copies 
of the annual progress report of postmarketing studies to FDA under 
Sec.  601.70(d).
    Under Sec. Sec.  601.91 through 601.94, FDA expects to receive very 
few applications for these products; however, for calculation purposes, 
FDA is estimating the annual submission of one application. Under 
Sec. Sec.  601.93(b)(3) and 601.94, FDA estimates 240 hours for a 
manufacturer of a new biological product to develop patient labeling, 
and to submit the appropriate information and promotional labeling to 
FDA. The majority of the burden for developing the patient labeling is 
included under the reporting requirements for Sec.  601.94, therefore 
minimal burden is calculated for providing the guide to patients under 
Sec.  601.91(b)(3).
    There were a total of 5,338 amendments to an unapproved application 
or supplement and resubmissions submitted using Form FDA 356h.
    In the Federal Register of January 26, 2010 (75 FR 4081), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on this 
information collection request.
    FDA estimates the burden of this collection of information as 
follows:

                                                    Table 1. -- Estimated Annual Reporting Burden\1\
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                                                                        No. of       Annual Frequency    Total Annual      Hours per
                 21 CFR Section                     Form FDA No.     Respondents       per Response       Responses         Response       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a)\2\, 610.60 through 610.65\3\                   2567/356h               23                  2               46              860           39,560
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601.5(a)                                                       NA               11                  3               33       20 minutes               11
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601.6(a)                                                       NA                1                 21               21       20 minutes                7
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601.12(a)(5)                                                   NA              802                  9            7,218                1            7,218
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(b)(1)/(b)(3)/(e)\4\                               356h \2\              166                  5              830               80           66,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(c)(1)/(c)(3)\5\                                   356h \2\              141                  5              705               50           35,250
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601.12(c)(5)                                             356h \2\               42                  5              210               50           10,500
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601.12(d)(1)/(d)(3)/(f)(3)\7\                            356h \2\              246                  3              738               23           16,974
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601.12(f)(1)\6\                                              2567              112                  2              224               40            8,960
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601.12(f)(2)\6\                                              2567               53                  3              159               20            3,180
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601.12(f)(4)/601.45                                     2567/2253               42                106            4,452               10           44,520
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601.26(f)                                                      NA                1                  1                1                1                1
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601.27(b)                                                      NA                6                  1                6               24              144
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601.27(c)                                                      NA               10                  1               10                8               80
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601.70(b) and (d)/601.28                                     2252               39                  2               78               24            1,872
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601.91(b)(3), 601.94                                           NA                1                  1                1              240              240
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680.1(c)                                                       NA                9                  1                9                2               18
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680.1(b)(3)(iv)                                                NA                1                  1                1                2                2
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[[Page 32790]]


Amendments/Resubmissions                                     356h              314                 17            5,338               20          106,760
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TOTAL                                                                                                                                            341,697
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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.   610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
  640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec.   601.2(a).
\3\ The reporting requirements under Sec.  Sec.   640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and (c),
  660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under Sec.  Sec.   610.60 through 610.65.
\4\ The reporting requirements under Sec.  Sec.   610.9(a), 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
  640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec.   601.12(b).
\5\ The reporting requirements under Sec.  Sec.   610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under Sec.
  601.12(c).
\6\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(1) and (f)(2).
\7\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(3).

    Under table 2 of this document, the estimated recordkeeping burden 
of 1 hour is based on previous estimates for the recordkeeping 
requirements associated with the AER (Adverse Event Reports) system.

                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR           No. of         Annual Frequency      Total Annual          Hours per
   Section        Respondents        per Response          Responses           Response           Total Hours
----------------------------------------------------------------------------------------------------------------
601.91(b)(2)                   1                   1                   1                   1                   1
 (iii)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: June 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-13815 Filed 6-8-10; 8:45 am]
BILLING CODE 4160-01-S

