Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format, 32392-32394 [2013-12825]
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32392
Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices
attending, and if participating via
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opportunities to present oral comments
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Dated: May 24, 2013.
Richard Olson,
Designated Federal Officer, Director, Division
of Prevention Science, Office of Disease
Prevention and Health Promotion, Office of
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Department of Health and Human Services.
TKELLEY on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2013–12859 Filed 5–24–13; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Health Resources and Services
Administration
CDC/HRSA Advisory Committee on
HIV, Viral Hepatitis and STD Prevention
and Treatment
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) and the
Health Resources and Services
Administration (HRSA) announce the
following meeting of the
aforementioned committee:
Times and Dates: 8:00 a.m.–5:30 p.m., June
18, 2013; 8:00 a.m.–2:30 p.m., June 19, 2013.
Place: CDC Corporate Square, Building 8,
Conference Room 1–ABC, 8 Corporate
Boulevard, Atlanta, Georgia 30329,
Telephone: (404) 639–8317.
Status: Open to the public, limited only by
the space available. The meeting room will
accommodate approximately 100 people.
This meeting is also accessible by
teleconference. Toll-free +1 (866) 718–4584,
Participant code: 8484551.
Status: Open to the public, limited only by
the space available. The meeting room will
accommodate approximately 100 people.
Purpose: This Committee is charged with
advising the Director, CDC and the
Administrator, HRSA, regarding activities
related to prevention and control of HIV/
AIDS, Viral Hepatitis and other STDs, the
support of health care services to persons
living with HIV/AIDS, and education of
health professionals and the public about
HIV/AIDS, Viral Hepatitis and other STDs.
Matters To Be Discussed: Agenda items
include: (1) STD clinical preventive services
in primary care setting and integrating STD
screening and treatment services in HIV care
settings); (2) The test and cure era for
hepatitis C: The public health response to
rising hepatitis C mortality; The impact of
new therapies on health outcomes; and
Building care capacity to increase access to
hepatitis C virus (HCV) therapy; (3) HIV
Medical Monitoring Project: follow up on
Institute of Medicine (IOM) report and other
Affordable Care Act (ACA) issues; (4)
Recommendations for new HIV diagnostic
laboratory testing algorithms; and (5) CHAC
Workgroups Update.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Margie Scott-Cseh, Centers for Disease
Control and Prevention, National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention, 1600 Clifton Road NE., Mailstop
E–07, Atlanta, Georgia 30333, Telephone
(404) 639–8317.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register Notices
pertaining to announcements of meetings and
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other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2013–12857 Filed 5–29–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0577]
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.
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 information collection contained in
the requirements for the submission of
labeling for human prescription drugs
and biologics in electronic format.
DATES: Submit either electronic or
written comments on the collection of
information by July 29, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
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., P150–
400B, Rockville, MD 20850, 301–796–
7726, Ila.mizrachi@fda.hhs.gov.
SUMMARY:
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Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices
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
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.
SUPPLEMENTARY INFORMATION:
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 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
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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 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
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32393
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 $20.00 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:
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Federal Register / Vol. 78, No. 104 / Thursday, May 30, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
1 There
Average
burden per
response
Total hours
11.50
5,750
1.25
7,187.50
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
BILLING CODE 4160–01–P
Experimental Study on Consumer
Responses to Nutrition Facts Labels
with Various Footnote Formats and
Declaration of Amount of Added
Sugars—(OMB Control Number 0910–
New)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0495]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study on Consumer Responses to
Nutrition Facts Labels With Various
Footnote Formats and Declaration of
Amount of Added Sugars
Food and Drug Administration,
HHS.
Notice.
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 July 1,
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–New and
title ‘‘Experimental Study on Consumer
Responses to Nutrition Facts Labels
with Various Footnote Formats and
Declaration of Amount of Added
Sugars.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850,
domini.bean@fda.hhs.gov.
SUMMARY:
TKELLEY on DSK3SPTVN1PROD with NOTICES
Total annual
responses
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–12825 Filed 5–29–13; 8:45 am]
ACTION:
Number of
responses per
response
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Number of
respondents
500
Content of labeling submissions in NDAs, ANDAs,
supplemental NDAs and ANDAs, and annual reports
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I. Background
Under the Nutrition Labeling and
Education Act of 1990 (Pub. L. 101–
535), the Nutrition Facts label is
required on most packaged foods and
this information must be provided in a
specific format in accordance with the
provisions of § 101.9 (21 CFR 101.9).
When FDA was determining which
Nutrition Facts label format to require,
the Agency undertook consumer
research to evaluate alternatives (Refs. 1
to 3). More recently, FDA conducted
qualitative consumer research on the
format of the Nutrition Facts label on
behalf of the Agency’s Obesity Working
Group (Ref. 4), which was formed in
2003 and tasked with outlining a plan
to help confront the problem of obesity
in the United States (Ref. 5). In addition
to conducting consumer research, in the
Federal Register of November 2, 2007
(72 FR 62149), FDA issued an Advance
Notice of Proposed Rulemaking
(ANPRM) entitled, ‘‘Food Labeling:
Revision of Reference Values and
Mandatory Nutrients’’ (the 2007
ANPRM), which requested comments
on a variety of topics related to a future
proposed rule to update the
presentation of nutrients and content of
nutrient values on food labels. In the
2007 ANPRM, the Agency included a
request for comments on how
consumers use the percent Daily Value
in the Nutrition Facts label when
evaluating the nutritional content of
food items and making purchases.
Research has suggested that
consumers use the Nutrition Facts label
in various ways, including, but not
limited to, using the Nutrition Facts
label to determine if products are high
or low in a specific nutrient and to
compare products (Ref. 6). One
component of the Nutrition Facts label
that serves as an aid in these uses is the
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percent Daily Value. Early consumer
research indicated that the percent Daily
Value format improved consumers’
abilities to make correct dietary
judgments about a food in the context of
a total daily diet (Ref. 3), which led FDA
to require both quantitative and
percentage declarations of nutrient
Daily Values in the Nutrition Facts label
in the 1993 Nutrition Labeling final rule
(58 FR 2079, January 6, 1993).
Research in subsequent years,
however, suggested that consumers’
understanding and use of percent Daily
Value may be somewhat inconsistent
(Refs. 7 and 8). Additionally, FDA has
received several public comments
suggesting that further research on
percent Daily Values may be warranted,
along with research on other
modifications to the Nutrition Facts
label. Suggested research on potential
modifications includes research on: (1)
The removal of the statements, ‘‘Percent
Daily Values are based on a 2,000
calorie diet. Your Daily Values may be
higher or lower depending on your
calorie needs’’; (2) the removal of the
table in the footnote that lists the Daily
Values for total fat, saturated fat,
cholesterol, sodium, total carbohydrate,
and dietary fiber based on 2,000 and
2,500 calorie diets as described in
§ 101.9(d)(9); and (3) changes to the
presentation of and amount of
information provided in the Nutrition
Facts label. Therefore, the FDA, as part
of its effort to promote public health,
proposes to use this study to explore
consumer responses to various food
label formats for the footnote area of the
Nutrition Facts label, including those
that exhibit information such as a
description of percent Daily Value, a
succinct statement about daily caloric
intake, a general guideline for
interpreting percent Daily Values, or a
footnote about nutrients whose daily
intake should be limited.
This study will also explore how
declaring the added sugars content of
foods might affect consumers’ attention
to and understanding of the sugars and
calorie contents and other information
on the Nutrition Facts label. FDA
received numerous comments regarding
the declaration of added sugars in
response to the 2007 ANPRM even
though the Agency did not ask any
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]]>Agencies
[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32392-32394]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12825]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0577]
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
(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 information collection
contained in the requirements for the submission of labeling for human
prescription drugs and biologics in electronic format.
DATES: Submit either electronic or written comments on the collection
of information by July 29, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to https://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., P150-400B,
Rockville, MD 20850, 301-796-7726, Ila.mizrachi@fda.hhs.gov.
[[Page 32393]]
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
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.
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 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 $20.00 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:
[[Page 32394]]
Table 1--Estimated Annual Reporting Burden \1\
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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 5,750 1.25 7,187.50
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12825 Filed 5-29-13; 8:45 am]
BILLING CODE 4160-01-P
