Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, 57491-57493 [E9-26760]
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Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
Dated: October 29, 2009.
Mark R. Johnston,
Deputy Assistant Secretary for Special Needs.
0367, 54–0483, 54–1027, 54–1028, 54–
1030, 54–1041
Reasons: Extensive deterioration, Secured
Area.
TITLE V, FEDERAL SURPLUS PROPERTY
PROGRAM FEDERAL REGISTER REPORT
FOR 11/06/2009
[FR Doc. E9–26420 Filed 11–5–09; 8:45 am]
BILLING CODE 4210–67–P
Suitable/Available Properties
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Building
Montana
Bldg. 743
Glacier National Park
West Glacier MT 59921
Landholding Agency: GSA
Property Number: 54200940005
Status: Surplus
GSA Number: 7–I–MT–0544–AB
Comments: 678 sq. ft., most recent use—
dormitory, off-site use only.
Bldg. 744
Glacier National Park
West Glacier MT 59936
Landholding Agency: GSA
Property Number: 54200940006
Status: Surplus
GSA Number: 7–I–MT–0544AA
Comments: 1812 sq. ft., most recent use—
dormitory, off-site use only.
Update to the Report on Residual
Radioactive and Beryllium
Contamination at Atomic Weapons
Employer Facilities and Beryllium
Vendor Facilities
AGENCY: National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
Suitable/Available Properties
Land
Missouri
Tract LLWAS K3 Mexico City Ave.
Kansas City MO 64153
Landholding Agency: GSA
Property Number: 54200940004
Status: Surplus
GSA Number: 7–U–MO–0687AA
Comments: 0.034 w/easements.
Unsuitable Properties
Building
Guam
9 Bldgs.
Naval Base
Piti GU
Landholding Agency: Navy
Property Number: 77200940006
Status: Unutilized
Directions: 92, 204, 211NH, 292, 453, 454,
4407PP, 5120, 5125
Reasons: Extensive deterioration, Secured
Area.
mstockstill on DSKH9S0YB1PROD with NOTICES6
Unsuitable Properties
Building
Hawaii
Kauhola Point Lighthouse
Kauhola Point HI
Landholding Agency: Coast Guard
Property Number: 88200940001
Status: Unutilized
Reasons: Extensive deterioration.
New Mexico
13 Bldgs.
Los Alamos National Lab
Los Alamos NM 87545
Landholding Agency: Energy
Property Number: 41200940004
Status: Unutilized
Directions: 54–0306, 54–0315, 54–0324, 54–
0325, 54–1058, 54–0296, 54–0304, 54–
VerDate Nov<24>2008
18:23 Nov 05, 2009
Jkt 220001
SUMMARY: HHS gives notice of the
release of an update to The Report on
Residual Radioactive and Beryllium
Contamination at Atomic Weapons
Employer Facilities and Beryllium
Vendor Facilities under the Energy
Employees Occupational Illness
Compensation Program Act of 2000
(EEOICPA), 42 U.S.C. 7484–7385.
This update is the third revision to
the original report. The original report
was issued in November, 2002; the first
update was issued in October, 2003; and
the second update was issued in
December, 2006. The purpose of the
original report and subsequent updates
is to evaluate whether significant
residual contamination remained at
atomic weapons employer or beryllium
vendor facilities after such facilities had
concluded work for the Department of
Energy (DOE) or its predecessor
agencies.
NIOSH was required to submit the
original report by section 3151(b) of the
National Defense Authorization Act for
Fiscal Year 2002, Public Law 107–107
(December 18, 2001), which amended
EEOICPA. EEOICPA was amended again
in section 3169 of the National Defense
Authorization Act of Fiscal Year 2005,
Public Law 108–375 (October 28, 2004)
which directed NIOSH to update the
residual contamination report by
December, 2006.
This third revision to the original
report has been prepared because the
determination of residual contamination
for several sites has changed since the
issuance of the December 2006 version
of the report. Specifically, this updated
report is being submitted due to several
recent changes in facility designations
by DOE and the Department of Labor,
and due to new information for certain
facilities that was acquired and
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57491
evaluated since the issuance of the
December 2006 version of the report.
DOE uses the designations in this
report to modify its publicly available
list of EEOICPA-covered facilities,
which includes the time periods
determined by DOL to be covered under
EEOICPA.
The entire report can be viewed on
the Office of Compensation and
Analysis Support Web site at https://
www.cdc.gov/niosh/ocas/.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Interim Director,
Office of Compensation Analysis and
Support, National Institute for
Occupational Safety and Health, 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 513–
533–6800 (this is not a toll-free
number).
Information requests can also be
submitted by e-mail to
OCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. E9–26843 Filed 11–5–09; 8:45 am]
BILLING CODE 4160–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0507]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Requirements for
Submission of Labeling for Human
Prescription Drugs and Biologics in
Electronic Format
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995,
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 reporting requirements contained in
the requirements for submission of
labeling for human prescription drugs
and biologics in electronic format.
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57492
Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
DATES: Submit written or electronic
comments on the collection of
information by January 5, 2010.
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Dockets Management
Branch (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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
Elizabeth.Berbakos@fda.hhs.gov, 301–
796–3792
Under the
Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501–3520, Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on: (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.
mstockstill on DSKH9S0YB1PROD with NOTICES6
SUPPLEMENTARY INFORMATION:
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18:23 Nov 05, 2009
Jkt 220001
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 USC 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
Biologics License Applications, 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.
When we last requested that OMB
extend approval for this information
collection (see the Federal Register of
March 29, 2006 (71 FR 15752)), we
received several comments. Generally,
the comments said that, unlike FDA’s
December 11, 2003, final rule, the
agency has now identified Extensible
Markup Language (XML) as the required
file format for Structured Product Label
documents (SPL), and that the burden
hours and costs that were calculated in
the final rule were based on the
submission of the content of labeling in
PDF. The comments said that the
burden estimate in March 29, 2006,
Federal Register notice does not take
into account the amount of time
required to obtain, install, and update
the program required to create the
electronic files in the new format, and
that SPL is a relatively new format
requiring an initial investment in
software, training, and process change
that cannot simply be converted from
the Word or PDF version of labeling.
PO 00000
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Fmt 4703
Sfmt 4703
The comments said that the process for
creating the SPL labeling includes
significant effort in mapping, coding,
recreation of the file, and quality
control.
In the December 13, 2006, Federal
Register (71 FR 74924), we said that we
will respond to the comments as soon
as we have gathered sufficient
information to address the costs
specified in the comments, and that the
public will have an opportunity to
comment on the response at that time.
The burden hours and costs associated
with making these submissions using
the SPL standard are discussed here.
We estimate that it should take
applicants approximately 1.25 hours to
convert the content of labeling from
Word or PDF to 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
2006, 2007, and 2008, we estimate that
approximately 5,000 content of labeling
submissions are made annually with
original NDAs, ANDAs, supplemental
NDAs and ANDAs, and annual reports
by approximately 450 applicants.
Therefore, the total annual hours to
convert the content of labeling from
Word or PDF to SPL format would be
approximately 6,250 hours.
Concerning costs, we continue to
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
E:\FR\FM\06NON1.SGM
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57493
Federal Register / Vol. 74, No. 214 / Friday, November 6, 2009 / Notices
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 $20.00 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.
Number of
respondents
Content of labeling submissions in
NDAs, ANDAs, supplemental
NDAs and ANDAs, and annual
reports
Annual frequency
per Response
450
Total Annual
Responses
11.11
Hours per
Response
5,000
Total Hours
1.25
6,250
There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26760 Filed 11–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on September 2nd, 2009 and
allowed 60 days for public comment.
One comment was received. The
purpose of this notice is to allow an
additional 30 days for public comment.
Agency for Healthcare Research and
Quality
DATES: Comments on this notice must be
received by December 7, 2009.
Agency Information Collection
Activities: Proposed Collection;
Comment Request
ADDRESSES:
AGENCY: Agency for Healthcare Research
and Quality, HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES6
ACTION:
Notice.
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Collection of Information for Agency
for Healthcare Research and Quality’s
(AHRQ) Hospital Survey on Patient
Safety Culture Comparative Database.’’
In accordance with the Paperwork
Reduction Act of 1995, 44 U.S.C.
3506(c)(2)(A), AHRQ invites the public
VerDate Nov<24>2008
18:23 Nov 05, 2009
Jkt 220001
Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by email at OIRA_submission@omb.eop.gov
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at doris.lefkowitz@ahrg.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Sfmt 4703
Proposed Project
Collection of Information for Agency for
Healthcare Research and Quality’s
(AHRQ) Hospital Survey on Patient
Safety Culture Comparative Database
The Agency for Healthcare Research
and Quality (AHRQ) requests that the
Office of Management and Budget
(OMB) approve, under the Paperwork
Reduction Act of 1995, AHRQ’s
collection of information for the AHRQ
Hospital Survey on Patient Safety
Culture (Hospital SOPS) Comparative
Database. The Hospital SOPS
Comparative Database consists of data
from the AHRQ Hospital Survey on
Patient Safety Culture. Hospitals in the
U.S. are asked to voluntarily submit
data from the survey to AHRQ, through
its contractor, Westat. The database was
developed by AHRQ in 2006 in
response to requests from hospitals
interested in knowing how their patient
safety culture survey results compare to
those of other hospitals in their efforts
to improve patient safety.
In 1999, the Institute of Medicine
called for health care organizations to
develop a ‘‘culture of safety’’ in which
their workforces and processes focus on
improving the reliability and safety of
care for patients (IOM, 1999; To Err is
Human: Building a Safer Health
E:\FR\FM\06NON1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 214 (Friday, November 6, 2009)]
[Notices]
[Pages 57491-57493]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26760]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0507]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Requirements for Submission of Labeling for Human
Prescription Drugs and Biologics in Electronic Format
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995,
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 reporting requirements contained in the
requirements for submission of labeling for human prescription drugs
and biologics in electronic format.
[[Page 57492]]
DATES: Submit written or electronic comments on the collection of
information by January 5, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. All comments should be identified with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, Elizabeth.Berbakos@fda.hhs.gov, 301-
796-3792
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501-3520, Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. ``Collection of information'' is
defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
With respect to the following collection of information, FDA
invites comments on: (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.
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 USC 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 Biologics License Applications, 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.
When we last requested that OMB extend approval for this
information collection (see the Federal Register of March 29, 2006 (71
FR 15752)), we received several comments. Generally, the comments said
that, unlike FDA's December 11, 2003, final rule, the agency has now
identified Extensible Markup Language (XML) as the required file format
for Structured Product Label documents (SPL), and that the burden hours
and costs that were calculated in the final rule were based on the
submission of the content of labeling in PDF. The comments said that
the burden estimate in March 29, 2006, Federal Register notice does not
take into account the amount of time required to obtain, install, and
update the program required to create the electronic files in the new
format, and that SPL is a relatively new format requiring an initial
investment in software, training, and process change that cannot simply
be converted from the Word or PDF version of labeling. The comments
said that the process for creating the SPL labeling includes
significant effort in mapping, coding, recreation of the file, and
quality control.
In the December 13, 2006, Federal Register (71 FR 74924), we said
that we will respond to the comments as soon as we have gathered
sufficient information to address the costs specified in the comments,
and that the public will have an opportunity to comment on the response
at that time. The burden hours and costs associated with making these
submissions using the SPL standard are discussed here.
We estimate that it should take applicants approximately 1.25 hours
to convert the content of labeling from Word or PDF to 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 2006, 2007, and 2008, we estimate that approximately 5,000
content of labeling submissions are made annually with original NDAs,
ANDAs, supplemental NDAs and ANDAs, and annual reports by approximately
450 applicants. Therefore, the total annual hours to convert the
content of labeling from Word or PDF to SPL format would be
approximately 6,250 hours.
Concerning costs, we continue to 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
[[Page 57493]]
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 $20.00 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.
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Number of Annual frequency Total Annual Hours per
respondents per Response Responses Response Total Hours
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Content of labeling submissions in NDAs, ANDAs, 450 11.11 5,000 1.25 6,250
supplemental NDAs and ANDAs, and annual reports
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There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26760 Filed 11-5-09; 8:45 am]
BILLING CODE 4160-01-S
