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, 4081-4086 [2010-1439]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Notices]
[Pages 4081-4086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1439]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

[[Page 4082]]

public comment in response to the notice. This notice solicits comments 
on the collection of information relating 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.

DATES: Submit written or electronic comments on the collection of 
information by March 29, 2010.

ADDRESSES:  Submit electronic comments on the collection of information 
to https://www.regulations.gov. 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: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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 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 (21 CFR 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 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.  
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 
Sec.  601.12(f)(4) in table 1 of this document.
    Section 601.12(b)(1), (b)(3), (c)(1), (c)(3), (c)(5), (d)(1), and 
(d)(3) requires 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

[[Page 4083]]

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 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. 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 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 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), and 680.1(b)(2)(iii) and 
(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 paragraph 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 (21 CFR 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 one 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 paragraph 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 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, 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.
    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 Control No. 
0910-0001). Under Sec.  601.70(d), two copies of the annual report 
shall be submitted to FDA.
    Sections 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 patients or potential patients for biological 
products approved under part 601, subpart H 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 subpart H are subject to the postmarketing recordkeeping 
and safety reporting applicable to all approved biological products. 
Section 601.94 requires applicants under subpart H to submit to the 
agency for consideration during preapproval review period copies of all 
promotional materials including promotional labeling as well as 
advertisements.

[[Page 4084]]

    Under Sec.  601.93, any potential postmarketing reports and/or 
recordkeeping burdens would be included under the adverse experience 
reporting (AER) requirements under part 600 (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 subpart H. 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) (21 CFR 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) (21 
CFR 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 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 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 in this document 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 4,452 
submissions of advertising and promotional labeling. FDA estimates that 
approximately 15 percent of those submissions were received with Form 
FDA 2567 and 85 percent 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,

[[Page 4085]]

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.
    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\ and 610.60 through 610.65\3\          2567/356h               23                  2                 46                860             39,560
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.5(a)                                                N/A               11                  3                 33         20 minutes                 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a)                                                N/A                1                 21                 21         20 minutes                  7
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(a)(5)                                            N/A              802                  9              7,218                  1              7,218
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(b)(1), (b)(3), and (e)\4\                    356h\2\              166                  5                830                 80             66,400
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(c)(1) and (c)(3)\5\                          356h\2\              141                  5                705                 50             35,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(c)(5)                                        356h\2\               42                  5                210                 50             10,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(d)(1), (d)(3), and (f)(3)\7\                 356h\2\              246                  3                738                 23             16,974
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(1)\6\                                        2567              112                  2                224                 40              8,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(2)\6\                                        2567               53                  3                159                 20              3,180
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.12(f)(4) and 601.45                           2567/2253               42                106              4,452                 10             44,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.26(f)                                               N/A                1                  1                  1                  1                  1
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.27(b)                                               N/A                6                  1                  6                 24                144
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.27(c)                                               N/A               10                  1                 10                  8                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.70(b), (d), and 601.28                             2252               39                  2                 78                 24              1,872
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.91(b)(3) and 601.94                                 N/A                1                  1                  1                240                240
--------------------------------------------------------------------------------------------------------------------------------------------------------
680.1(c)                                                N/A                9                  1                  9                  2                 18
--------------------------------------------------------------------------------------------------------------------------------------------------------
680.1(b)(3)(iv)                                         N/A                1                  1                  1                  2                  2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Amendments/Resubmissions                               356h              314                 17              5,338                 20            106,760
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                            341,697
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec.  Sec.   610.9(a), 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c),
  640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec.   601.2(a).
\3\ The reporting requirements under Sec.  Sec.   640.70(a), 640.74(b)(3) and (b)(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).


[[Page 4086]]

    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       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records        Hours per Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.91(b)(2)(iii)                                                       1                     1                  1                  1                  1
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.


    Dated: January 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-1439 Filed 1-25-10; 8:45 am]
BILLING CODE 4160-01-S