Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, 56715-56717 [2013-22312]
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56715
Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Instrument
Total number
of respondents
Annual number
of respondents
Number of responses
per respondent
Average
burden hours
per response
Data file submission .....................................................
Administrative Data Study annual burden hours .................
15
........................
5
........................
4
........................
0.6
........................
12
12
OVERALL ANNUAL BURDEN HOURS ................
........................
........................
........................
........................
4,418
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: OPRE Reports Clearance
Officer. Email address:
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2013–22310 Filed 9–12–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Total
annual
burden hours
OMB No.: 0970–0157.
Description: 42 U.S.C. 612 (Section
412 of the Social Security Act) requires
each Indian Tribe that elects to
administer and operate a Temporary
Assistance for Needy Families (TANF)
program to submit a TANF Tribal Plan.
The TANF Tribal Plan is a mandatory
statement submitted to the Secretary by
the Indian Tribe, which consists of an
outline of how the Indian Tribes TANF
program will be administered and
operated. It is used by the Secretary to
determine whether the plan is
approvable and to determine that the
Indian Tribe is eligible to receive a
TANF assistance grant. It is also made
available to the public.
Respondents: Indian Tribes applying
to operate a TANF program.
Submission for OMB Review;
Comment Request
Title: Guidance for Tribal TANF.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total
burden hours
Request for State Data Needed to Determine the Amount of a Tribal Family
Assistance Grant ..........................................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Instrument
23
1
68
1564
Estimated Total Annual Burden
Hours: 1,564.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
VerDate Mar<15>2010
18:23 Sep 12, 2013
Jkt 229001
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–7285,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–22252 Filed 9–12–13; 8:45 am]
BILLING CODE 4184–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0577]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Requirements for
Submission of Labeling for Human
Prescription Drugs and Biologics in
Electronic Format
AGENCY:
ACTION:
Sfmt 4703
Food and Drug Administration,
HHS.
E:\FR\FM\13SEN1.SGM
Notice.
13SEN1
56716
Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices
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 October 15,
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 0910–0530. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
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.
FOR FURTHER INFORMATION CONTACT:
tkelley on DSK3SPTVN1PROD with NOTICES
Requirements for Submission of
Labeling for Human Prescription Drugs
and Biologics in Electronic Format—
(OMB Control Number 0910–0530)—
Extension
FDA is requesting that OMB extend
approval under the Paperwork
Reduction Act (44 U.S.C. 3501–3520) for
the information collection resulting
from the requirement that the content of
labeling for prescription drug products
be submitted to FDA electronically in a
form that FDA can process, review, and
archive. This requirement was set forth
in the final rule entitled ‘‘Requirements
for Submission of Labeling for Human
Prescription Drugs and Biologics in
Electronic Format’’ (December 11, 2003;
68 FR 69009), which amended FDA
regulations governing the format in
which certain labeling is required to be
submitted for FDA review with new
drug applications (NDAs) (21 CFR
314.50(l)(1)(i)), including supplemental
NDAs, abbreviated new drug
applications (ANDAs) (21 CFR
314.94(d)(1)(ii)), including
supplemental ANDAs, and annual
reports (21 CFR 314.81(b)(2)(iii)(b)) (the
final rule also applied to certain BLAs,
but the information collection for these
requirements is not part of this OMB
approval request).
VerDate Mar<15>2010
18:23 Sep 12, 2013
Jkt 229001
This OMB approval request is only for
the burden associated with the
electronic submission of the content of
labeling. The burden for submitting
labeling as part of NDAs, ANDAs,
supplemental NDAs and ANDAs, and
annual reports, has been approved by
OMB under control number 0910–0001.
We estimate that it should take
applicants approximately 1.25 hours to
convert the content of labeling from
Word or PDF to structured labeling
format (SPL) format. The main task
involved in this conversion is copying
the content from one document (Word
or PDF) to another (SPL). Over the past
few years, several enhancements have
been made to SPL authoring software
which significantly reduces the burden
and time needed to generate wellformed SPL documents. SPL authors
may now copy a paragraph from a Word
or PDF document and paste the text into
the appropriate section of an SPL
document. In those cases where an SPL
author needs to create a table, the table
text may be copied from the Word or
PDF document and pasted into each
table cell in the SPL document,
eliminating the need to retype any
information. Enhancements have also
been made to the software for
conversion vendors. Conversion
software vendors have designed tools
which will import the Word version of
the content of labeling and, within
minutes, automatically generate the SPL
document (a few formatting edits may
have to be made).
Based on the number of content of
labeling submissions received during
the past few years, we estimate that
approximately 5,750 content of labeling
submissions are made annually with
original NDAs, ANDAs, supplemental
NDAs and ANDAs, and annual reports
by approximately 500 applicants.
Therefore, the total annual hours to
convert the content of labeling from
Word or PDF to SPL format would be
approximately 7,187.50 hours.
Concerning costs, we conclude that
there are no capital costs or operating
and maintenance costs associated with
this collection of information. In May
2009, FDA issued a guidance for
industry entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Listing.’’ The guidance describes how to
electronically create and submit SPL
files using defined code sets and codes
for establishment registration and drug
listing information, including labeling.
The information collection resulting
from this guidance, discussed in the
Federal Register of January 8, 2009 (74
FR 816), has been approved by OMB
under control number 0910–0045. As
PO 00000
Frm 00071
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discussed in the January 8, 2009,
Federal Register notice, to create an SPL
file and submit it to FDA, a registrant
would need the following tools: A
computer, appropriate software, access
to the Internet, knowledge of
terminology and standards, and access
to FDA’s electronic submission gateway
(ESG). Registrants (and most
individuals) have computers and
Internet access available for their use. If
a business does not have an available
computer or access to the Internet, free
use of computers and the Internet are
usually available at public facilities,
e.g., a community library. In addition,
there should be no additional costs
associated with obtaining the
appropriate software. In 2008, FDA
collaborated with GlobalSubmit to make
available free SPL authoring software
that SPL authors may utilize to create
new SPL documents or edit previous
versions. (Information on obtaining this
software is explained in section IV.A of
the guidance ‘‘Providing Regulatory
Submissions in Electronic Format—
Drug Establishment Registration and
Listing.’’) In addition to the software,
FDA also provides technical assistance
and other resources, code sets and
codes, and data standards regarding SPL
files.
After the SPL file is created, the
registrant would upload the file through
the ESG, as explained in the January 8,
2009, Federal Register notice. A digital
certificate is needed to use the ESG. The
digital certificate binds together the
owner’s name and a pair of electronic
keys (a public key and a private key)
that can be used to encrypt and sign
documents. A fee of up to $20 is
charged for the digital certificate and the
registrant may need to renew the
certificate not less than annually. We
are not calculating this fee as a cost for
this extension because all applicants
who submit content of labeling are also
subject to the drug establishment
registration and listing requirements
and would have already acquired the
digital certificate as a result of the May
2009 guidance on drug establishment
registration and listing.
In the Federal Register of May 30,
2013 (78 FR 32392), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. There were two comments
received. Both comments disagreed with
FDA’s estimate of 1.25 hours for
converting the content of labeling to
SPL format. One comment said it would
take 4 to 12 hours for experienced users
to develop the initial well-formed SPL
and 4–5 hours for an SPL update, and
that these estimates vary depending on
the complexity of the labeling metadata
E:\FR\FM\13SEN1.SGM
13SEN1
Federal Register / Vol. 78, No. 178 / Friday, September 13, 2013 / Notices
and whether changes are necessary. The
comment said that FDA also needs to
account for the time required for
validating the SPL extensible markup
language (XML) file, including the need
for using at least one XML validation
tool to ensure that the SPL file set is
well-formed and error-free. The
comment said that copying table cells to
create an SPL file is time consuming
and prone to errors, and that software
tools do not allow users to copy and
paste the text and render it as intended
in SPL. The comment said that most
users need to apply applicable
formatting to tables, which leads to
longer conversion timelines, and that
manually creating the SPL file and
proofing the document is timeconsuming.
One comment said that updating the
SPL file for submission to FDA when a
non-annotated or partially annotated
MS Word document is received from
FDA requires a significant amount of
time to identify the changes to the
labeling. The comment said that
although SPL is a useful and necessary
format it involves extra time and costs
for staying current with changes in
terminology and software versions, and
for conversion from another format
when FDA requests documents in both
MS Word and SPL. The comment said
that maintaining multiple formats of
labeling, negotiating FDA comments,
and documenting agreements to final
labeling is time-consuming.
A comment requested that FDA use a
single, electronic file format for receipt,
review, and revision of labeling. The
comment said that companies currently
receive information from FDA during its
review of labeling in many formats,
including MS Word (both editable and
hard-formatted), faxes, texts, in emails,
or other scanned documents with
handwritten comments. The comment
noted that each iteration of the MS
Word document may need to be
converted to SPL for submission, and
that managing the same activities for
two different formats doubles the workload and causes incremental costs to be
incurred by companies. The comment
also said that there should be better
document management (e.g., version
control, tracking changes, and
validation) of the MS Word documents.
A comment said that the staffing,
expertise, and technical support
necessary to independently determine
the need for a labeling change is costly.
One comment preferred the use of MS
Word for labeling revisions and
negotiations with FDA, and said that
until FDA is able to revise labeling
using only SPL it should not require an
SPL submission until 14 days postapproval.
Concerning the need for a digital
certificate to use the ESG, one comment
said that companies may need to renew
the certificate ‘‘not less than annually.’’
The comment said that FDA should
maintain an accurate list of acceptable
56717
digital certificate vendors and
communicate the list to stakeholders via
a formal process, as well as issue
appropriate notice of changes. The
comment noted that some companies
received messages from FDA that one of
the vendors listed as an approved
certificate vendor was not acceptable for
use for submissions to FDA, and, as a
result, the companies purchased
multiple certificates from different
vendors in order to use the ESG.
A comment requested clarification
concerning the type of filing needed or
anticipated by FDA to make an
appropriate labeling decision. The
comment said that the Federal Register
notice is not clear about what type of
filing is needed ‘‘other than a CBE
[change being effected], which will not
allow the Agency adequate time to
review if the label change is solely
linked to one manufacturer or if it is
indeed a product related safety concern
applicable to an entire class of
pharmaceuticals.’’
FDA appreciates the comments. We
will respond to the issues raised in the
comments and amend this collection if
necessary as soon as we have gathered
sufficient information to address the
cost issues specified in the comments.
The public will have an opportunity to
comment on our response at that time.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Content of labeling submissions in NDAs, ANDAs,
supplemental NDAs and
ANDAs, and annual reports
Number of
responses
per response
Total annual
responses
Average
burden per
response
Total
hours
500
1 There
Number of
respondents
11.50
5750
1.25
7,187.50
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22312 Filed 9–12–13; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
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19:46 Sep 12, 2013
Jkt 229001
PO 00000
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E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56715-56717]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22312]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0577]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements for
Submission of Labeling for Human Prescription Drugs and Biologics in
Electronic Format
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 56716]]
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 October
15, 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 0910-0530.
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.
Requirements for Submission of Labeling for Human Prescription Drugs
and Biologics in Electronic Format--(OMB Control Number 0910-0530)--
Extension
FDA is requesting that OMB extend approval under the Paperwork
Reduction Act (44 U.S.C. 3501-3520) for the information collection
resulting from the requirement that the content of labeling for
prescription drug products be submitted to FDA electronically in a form
that FDA can process, review, and archive. This requirement was set
forth in the final rule entitled ``Requirements for Submission of
Labeling for Human Prescription Drugs and Biologics in Electronic
Format'' (December 11, 2003; 68 FR 69009), which amended FDA
regulations governing the format in which certain labeling is required
to be submitted for FDA review with new drug applications (NDAs) (21
CFR 314.50(l)(1)(i)), including supplemental NDAs, abbreviated new drug
applications (ANDAs) (21 CFR 314.94(d)(1)(ii)), including supplemental
ANDAs, and annual reports (21 CFR 314.81(b)(2)(iii)(b)) (the final rule
also applied to certain BLAs, but the information collection for these
requirements is not part of this OMB approval request).
This OMB approval request is only for the burden associated with
the electronic submission of the content of labeling. The burden for
submitting labeling as part of NDAs, ANDAs, supplemental NDAs and
ANDAs, and annual reports, has been approved by OMB under control
number 0910-0001.
We estimate that it should take applicants approximately 1.25 hours
to convert the content of labeling from Word or PDF to structured
labeling format (SPL) format. The main task involved in this conversion
is copying the content from one document (Word or PDF) to another
(SPL). Over the past few years, several enhancements have been made to
SPL authoring software which significantly reduces the burden and time
needed to generate well-formed SPL documents. SPL authors may now copy
a paragraph from a Word or PDF document and paste the text into the
appropriate section of an SPL document. In those cases where an SPL
author needs to create a table, the table text may be copied from the
Word or PDF document and pasted into each table cell in the SPL
document, eliminating the need to retype any information. Enhancements
have also been made to the software for conversion vendors. Conversion
software vendors have designed tools which will import the Word version
of the content of labeling and, within minutes, automatically generate
the SPL document (a few formatting edits may have to be made).
Based on the number of content of labeling submissions received
during the past few years, we estimate that approximately 5,750 content
of labeling submissions are made annually with original NDAs, ANDAs,
supplemental NDAs and ANDAs, and annual reports by approximately 500
applicants. Therefore, the total annual hours to convert the content of
labeling from Word or PDF to SPL format would be approximately 7,187.50
hours.
Concerning costs, we conclude that there are no capital costs or
operating and maintenance costs associated with this collection of
information. In May 2009, FDA issued a guidance for industry entitled
``Providing Regulatory Submissions in Electronic Format--Drug
Establishment Registration and Listing.'' The guidance describes how to
electronically create and submit SPL files using defined code sets and
codes for establishment registration and drug listing information,
including labeling. The information collection resulting from this
guidance, discussed in the Federal Register of January 8, 2009 (74 FR
816), has been approved by OMB under control number 0910-0045. As
discussed in the January 8, 2009, Federal Register notice, to create an
SPL file and submit it to FDA, a registrant would need the following
tools: A computer, appropriate software, access to the Internet,
knowledge of terminology and standards, and access to FDA's electronic
submission gateway (ESG). Registrants (and most individuals) have
computers and Internet access available for their use. If a business
does not have an available computer or access to the Internet, free use
of computers and the Internet are usually available at public
facilities, e.g., a community library. In addition, there should be no
additional costs associated with obtaining the appropriate software. In
2008, FDA collaborated with GlobalSubmit to make available free SPL
authoring software that SPL authors may utilize to create new SPL
documents or edit previous versions. (Information on obtaining this
software is explained in section IV.A of the guidance ``Providing
Regulatory Submissions in Electronic Format--Drug Establishment
Registration and Listing.'') In addition to the software, FDA also
provides technical assistance and other resources, code sets and codes,
and data standards regarding SPL files.
After the SPL file is created, the registrant would upload the file
through the ESG, as explained in the January 8, 2009, Federal Register
notice. A digital certificate is needed to use the ESG. The digital
certificate binds together the owner's name and a pair of electronic
keys (a public key and a private key) that can be used to encrypt and
sign documents. A fee of up to $20 is charged for the digital
certificate and the registrant may need to renew the certificate not
less than annually. We are not calculating this fee as a cost for this
extension because all applicants who submit content of labeling are
also subject to the drug establishment registration and listing
requirements and would have already acquired the digital certificate as
a result of the May 2009 guidance on drug establishment registration
and listing.
In the Federal Register of May 30, 2013 (78 FR 32392), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. There were two comments received. Both
comments disagreed with FDA's estimate of 1.25 hours for converting the
content of labeling to SPL format. One comment said it would take 4 to
12 hours for experienced users to develop the initial well-formed SPL
and 4-5 hours for an SPL update, and that these estimates vary
depending on the complexity of the labeling metadata
[[Page 56717]]
and whether changes are necessary. The comment said that FDA also needs
to account for the time required for validating the SPL extensible
markup language (XML) file, including the need for using at least one
XML validation tool to ensure that the SPL file set is well-formed and
error-free. The comment said that copying table cells to create an SPL
file is time consuming and prone to errors, and that software tools do
not allow users to copy and paste the text and render it as intended in
SPL. The comment said that most users need to apply applicable
formatting to tables, which leads to longer conversion timelines, and
that manually creating the SPL file and proofing the document is time-
consuming.
One comment said that updating the SPL file for submission to FDA
when a non-annotated or partially annotated MS Word document is
received from FDA requires a significant amount of time to identify the
changes to the labeling. The comment said that although SPL is a useful
and necessary format it involves extra time and costs for staying
current with changes in terminology and software versions, and for
conversion from another format when FDA requests documents in both MS
Word and SPL. The comment said that maintaining multiple formats of
labeling, negotiating FDA comments, and documenting agreements to final
labeling is time-consuming.
A comment requested that FDA use a single, electronic file format
for receipt, review, and revision of labeling. The comment said that
companies currently receive information from FDA during its review of
labeling in many formats, including MS Word (both editable and hard-
formatted), faxes, texts, in emails, or other scanned documents with
handwritten comments. The comment noted that each iteration of the MS
Word document may need to be converted to SPL for submission, and that
managing the same activities for two different formats doubles the
work-load and causes incremental costs to be incurred by companies. The
comment also said that there should be better document management
(e.g., version control, tracking changes, and validation) of the MS
Word documents. A comment said that the staffing, expertise, and
technical support necessary to independently determine the need for a
labeling change is costly.
One comment preferred the use of MS Word for labeling revisions and
negotiations with FDA, and said that until FDA is able to revise
labeling using only SPL it should not require an SPL submission until
14 days post-approval.
Concerning the need for a digital certificate to use the ESG, one
comment said that companies may need to renew the certificate ``not
less than annually.'' The comment said that FDA should maintain an
accurate list of acceptable digital certificate vendors and communicate
the list to stakeholders via a formal process, as well as issue
appropriate notice of changes. The comment noted that some companies
received messages from FDA that one of the vendors listed as an
approved certificate vendor was not acceptable for use for submissions
to FDA, and, as a result, the companies purchased multiple certificates
from different vendors in order to use the ESG.
A comment requested clarification concerning the type of filing
needed or anticipated by FDA to make an appropriate labeling decision.
The comment said that the Federal Register notice is not clear about
what type of filing is needed ``other than a CBE [change being
effected], which will not allow the Agency adequate time to review if
the label change is solely linked to one manufacturer or if it is
indeed a product related safety concern applicable to an entire class
of pharmaceuticals.''
FDA appreciates the comments. We will respond to the issues raised
in the comments and amend this collection if necessary as soon as we
have gathered sufficient information to address the cost issues
specified in the comments. The public will have an opportunity to
comment on our response at that time.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Content of labeling submissions in NDAs, ANDAs, supplemental NDAs Number of responses per Total annual Average burden Total hours
and ANDAs, and annual reports respondents response responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
500 11.50 5750 1.25 7,187.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22312 Filed 9-12-13; 8:45 am]
BILLING CODE 4160-01-P
