[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35273-35277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0578]


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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the 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 either electronic or written comments on the collection 
of information by August 12, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://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: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., Rockville, 
MD 20850, 301-796-7726, [email protected].

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

[[Page 35274]]

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 (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 of 1997 (Pub. L. 105-115) amended the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) by adding a new provision (section 506B of 
the FD&C Act (21 U.S.C. 356b)) requiring reports of postmarketing 
studies for approved human drugs and licensed biological products. 
Section 506B of the FD&C 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 FD&C 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 the 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. 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.
    Sections 601.12(b)(1), (b)(3), (c)(1), (c)(3), (c)(5), (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 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 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 the applicable regulations is 
included in the

[[Page 35275]]

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.  
640.74(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 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 number 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 
further burden for this regulation, and therefore this regulation is 
not included in table 1 of this document. 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, 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 to 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 
number 0910-0001). Under Sec.  601.70(d), two copies of the annual 
report shall be submitted to FDA.
    Sections 601.91 through 601.94 concern biological products for 
which human efficacy studies are not ethical or feasible. Section 
601.91(b)(2) requires, in certain circumstances, such postmarking 
restrictions as are needed to ensure the safe use of the biological 
product. 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. Under Sec. Sec.  
601.91(b)(2) and 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). Therefore, any burdens associated with these requirements 
would be reported under the AER information collection requirements 
(OMB control number 0910-0308). The burden estimate for Sec.  
601.91(b)(3) is included in the estimate under Sec. Sec.  610.60 
through 610.65.
    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,

[[Page 35276]]

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.
    Under Sec.  610.15(d), the Director of CBER or the Director of CDER 
may approve, as appropriate, a manufacturer's request for exceptions or 
alternatives to the regulation for constituent materials. Manufacturers 
seeking approval of an exception or alternative must submit a request 
in writing with a brief statement describing the basis for the request 
and the supporting data.
    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) (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. As such, the form, now entitled ``Application to 
Market a New or Abbreviated New Drug or Biologic for Human Use'' 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. In addition, 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 Form FDA 356h are approved under OMB control 
number 0910-0001 (an estimated 3,200 submissions x 24 hours = 76,800 
hours).
    Form FDA 2567 ``Transmittal of Labels and Circulars'' may be 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. 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 number 0910-0001.
    Under tables 1 and 2 of this document, the numbers of respondents 
are 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 2012. Based on information obtained from 
FDA's database systems, there are an estimated 323 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. 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 10,758 
submissions of advertising and promotional labeling.
    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.  610.15(d), FDA has received no submissions since the 
implementation of the final rule in April 2011. Therefore, FDA is 
estimating one respondent and one annual request to account for a 
possible submission to CBER or CDER of a request for an exception or 
alternative for constituent materials under Sec.  610.15(d).
    There were a total of 2,664 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:

[[Page 35277]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                     21 CFR Section                        Form FDA No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a),\2\ 610.60 through 610.65 \3\..................       2567/356h              25            1.8               45          860             38,700
601.5(a)................................................              NA               8            1                  8          * 0.33            2.64
601.6(a)................................................              NA               1            1                  1          * 0.33            0.33
601.12(a)(5)............................................              NA             791           16.51          13,057            1             13,057
601.12(b)(1)/(b)(3)/(e) \4\.............................        \2\ 356h             174            4.01             698           80             55,840
601.12(c)(1)/(c)(3) \5\.................................        \2\ 356h             117            4.60             538           50             26,900
601.12(c)(5)............................................        \2\ 356h              18            1.61              29           50              1,450
601.12(d)(1)/(d)(3) \6\/(f)(3) \8\......................        \2\ 356h             241            3.08             742           24             17,808
601.12(f)(1) \7\........................................            2567              67            2.48             166           40              6,640
601.12(f)(2) \7\........................................            2567              72            1.78             128           20              2,560
601.12(f)(4)/601.45 \9\.................................       2567/2253             102          103.71          10,578           10            105,780
601.26(f)...............................................              NA               1            1                  1            1                  1
601.27(b)...............................................              NA               4            1                  4           24                 96
601.27(c)...............................................              NA               6            1                  6            8                 48
601.70(b) and (d)/601.28................................            2252              56            1.91             107           24              2,568
610.15(d)...............................................              NA               1            1                  1            1                  1
680.1(c)................................................              NA               9            1                  9            2                 18
680.1(b)(3)(iv).........................................              NA               1            1                  1            2                  2
Amendments/Resubmissions................................            356h             207           12.87           2,664           20             53,280
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............         324,752
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, 610.9(a), 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.   601.93(b)(3), 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.   601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 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.   601.12(a)(2), 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.   601.12(a)(2) is included in the estimate under Sec.   601.12(d).
\7\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(1) and (f)(2).
\8\ The reporting requirement under Sec.  Sec.   601.12(a)(4) and 601.14 is included in the estimate under Sec.   601.12(f)(3).
\9\ The reporting requirement under Sec.   601.94 is included in the estimate under Sec.   601.45.
* 20 minutes.

    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 Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                           21 CFR Section                               Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a)...........................................................               1               20               20           * 0.33              6.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 20 minutes.


    Dated: June 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13896 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P