[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
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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
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Total............................................... .............. .............. .............. .............. .............. 324,752
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec. Sec. 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(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\
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Annual
21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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601.6(a)........................................................... 1 20 20 * 0.33 6.6
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\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