Document ID: FDA-2013-N-0578-0002
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2013-10-31T04:00Z

[Federal Register Volume 78, Number 211 (Thursday, October 31, 2013)]
[Notices]
[Pages 65334-65338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25961]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 
December 2, 2013.

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 emailed 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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.

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--
(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 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 Biologics Licensing Application (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

[[Page 65335]]

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), (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 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 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 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 
than 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 radiopharmaceuticals intended for in vivo 
administration for diagnostic and monitoring use. 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

[[Page 65336]]

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 postmarketing 
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.  
601.91(b)(2) and Sec.  601.93, any potential postmarketing reports and/
or recordkeeping burdens would be included under the adverse experience 
reporting (AER) requirements under 21 CFR part 600 (OMB control number 
0910-0308). 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) (21 CFR 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) (21 CFR 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.
    Under 21 CFR 610.15(d) (21 CFR 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 establishments to submit a request for an 
exception or alternative to any requirement in the biologics 
regulations regarding blood, blood components, or blood products. For 
licensed establishments, a request for an exception or alternative must 
be submitted in accordance with Sec.  601.12. 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. 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 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

[[Page 65337]]

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 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 10,578 
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 21 CFR 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.
    In the Federal Register of June 12, 2013 (78 FR 35273), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             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), 640.70(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.   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.

[[Page 65338]]

                                               Table 2--Estimated Annual Third Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                           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: October 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25961 Filed 10-30-13; 8:45 am]
BILLING CODE 4160-01-P