Agency Information Collection Activities; Proposed Collection; Comment Request; Invitation to Manufacturers and Distributors to Voluntarily Submit Final Product Labeling and Information Electronically for all Devices Cleared by the Food and Drug Administration for Home Use; Notice of Pilot Program, 27791-27793 [2010-11810]
Download as PDF
Federal Register / Vol. 75, No. 95 / Tuesday, May 18, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0229]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Invitation to
Manufacturers and Distributors to
Voluntarily Submit Final Product
Labeling and Information
Electronically for all Devices Cleared
by the Food and Drug Administration
for Home Use; Notice of Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on DSKH9S0YB1PROD with NOTICES
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments
regarding the request that manufacturers
and distributors of all devices cleared by
FDA for home use voluntarily submit
final product labeling and information
electronically as a part of a pilot
program to be conducted by FDA’s
Center for Devices and Radiological
Health (CDRH). FDA is requesting that
manufacturers and distributors for these
products submit final product labeling
and information in a standard
Structured Product Labeling (SPL)
format that we intend to eventually
place on a home use device product
portal that will be accessible to the
public.
DATES: Submit written or electronic
comments on the collection of
information by July 19, 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 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:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
VerDate Mar<15>2010
17:22 May 17, 2010
Jkt 220001
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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
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.
Invitation to Manufacturers and
Distributors of Devices Cleared by FDA
for Home Use to Voluntarily Submit
Final Product Labeling and Information
Electronically (OMB Control Number
0910—New)
For purposes of this pilot program,
FDA generally considers a home use
device to be a medical device intended
for users in a non-clinical environment
that is managed partly or wholly by the
user, where the device may require
adequate labeling for home use and may
require training by a licensed heath care
provider in order to be used safely and
effectively.
In June 2001, FDA created the Center
for Devices and Radiological Health
(CDRH) Home Health Care Committee
(HHCC) to review CDRH’s involvement
in addressing problems that arise when
devices are used in the home
environment. After meeting with
various stakeholders, the HHCC agreed
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Frm 00091
Fmt 4703
Sfmt 4703
27791
with the stakeholders’ recommendation
that promoting the safe use of medical
devices presented a significant health
challenge for which the HHCC could
focus CDRH’s educational outreach
efforts. As a result, FDA is seeking
manufacturers and distributors of
devices cleared for home use to
voluntarily participate in a pilot
program involving the submission of
final product labeling and additional
product information electronically.
Section 510(j)(1)(B)(i) of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360(j)(1)(B)(i)), requires
persons who register and list a restricted
device to provide, among other things,
a copy of all labeling to FDA. Section
510(j)(1)(B)(ii) of the act requires
persons who register and list a device
that is not restricted to provide the label
and package insert and a representative
sampling of any other labeling to FDA.
For this pilot program, we are
requesting manufacturers and
distributors of medical devices cleared
for home use to electronically submit
final product labeling as well as the
following information, if not included
in product labeling:
Device Product Information
Proprietary name
Descriptive name
Model or catalog number
FDA listing number
Manufacturer Information
Manufacturer name
Manufacturer address
Manufacturer 800 number
Manufacturer Web site
Distributor Information
Distributor name
Distributor address
Distributor 800 number
Distributor Web site
Characteristics
Allergens
Single use or reusable
Sterile
Storage temperature
Storage humidity
Size
Storage environment
Picture of device
MRI compatible
Marketing Information
Status
Prescription or OTC
Components and Accessories
Components needed to operate the
device
Accessories compatible with the
device
Pictures of components and
compatible accessories
Directions for Use
Intended use of the device
Indications for use
Route, method, and frequency of
administration
E:\FR\FM\18MYN1.SGM
18MYN1
27792
Federal Register / Vol. 75, No. 95 / Tuesday, May 18, 2010 / Notices
Summary of safety and effectiveness
Assembly or installation instructions
Calibration instructions
Instructions for use for the layperson
Warnings
Precautions
Contraindications
Side effects
Cleaning, disinfecting, and
sterilization instructions
Safety information
In Vitro Diagnostic Devices
Test code
Value range
Special information for this test
If this information is not a part of your
current final product labeling or
information, FDA is requesting that you
submit the information as a part of this
pilot program. The purpose of the pilot
program is twofold. First the pilot
program will enable regulated industry
to provide feedback that will assist FDA
in developing guidance for industry on
the electronic submission and
availability of final labeling and product
information for devices cleared for
home use. Second, the pilot program
will enable the public and regulated
industry to view the information and
instructions for use for such devices as
a part of CDRH’s planned medical
device portal for devices cleared for
home use. It is our expectation that the
portal, established as a part of this pilot
program, will increase the likelihood
that users—home health nurses,
patients, and caregivers—will have
continuous access to home use labeling
information and instructions for use to
help ensure the safe and effective use of
devices cleared for home use. In order
for manufacturers and distributors to
submit final labeling and product
information they will need to do so in
the SPL format. To create an SPL file
and submit it to FDA, a respondent
would need the following tools: A
computer, appropriate software, access
to the Internet, knowledge of
terminology and standards, and access
to FDA’s Electronic Submissions
Gateway (ESG) (https://www.fda.gov/
ForIndustry/ElectronicSubmissions
Gateway/default.htm). The ESG is an
agency-wide means for accepting
electronic regulatory submissions. The
FDA ESG enables the secure submission
of regulatory submissions. Instructions
and information regarding the creation
of an SPL file can be found at https://
www.fda.gov/ForIndustry/Data
Standards/StructuredProductLabeling/
default.htm. Most respondents 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
cost associated with obtaining the
software. In 2008, FDA collaborated
with GlobalSubmit (https://
globalsubmit.com/home/Home/tabid/
37/Default.aspx) to make available free
SPL authoring software that SPL authors
may utilize to create new SPL
documents or edit previous versions.
After the SPL is created, the respondent
would upload the file through the ESG.
The Internet portal can be found at
https://www.fda.gov/downloads/
ForIndustry/FDAeSubmitter/
UCM162419.pdf. Prior to uploading an
SPL file, one must obtain a digital
certificate. Instructions regarding
obtaining a digital certificate used with
FDA’s ESG and uploading the SPL file
for submission can be found at
www.fda.gov/esg/default.htm. The
digital certificate binds together the
owner’s name and a pair of electronic
keys (a public and a private key) that
can be used to encrypt and sign
documents. A fee of up to
approximately $20.00 is charged for the
digital certificate. FDA is not calculating
this small fee as cost of this information
collection because manufacturers and
distributors will have already secured a
digital certificate as they are required to
do so when they register and list.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Activity
Annual Frequency
per Response
Total Annual
Respondents
Hours per
Response
Total Hours
Collecting Final Labeling and Product
Information
200
3
600
2
1,200
Conversion of Word or PDF Final Labeling and Product Information into
SPL
200
3
600
2
1,200
Submission of SPL into ESG
200
3
600
1
600
Total
mstockstill on DSKH9S0YB1PROD with NOTICES
1There
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that the collection of
final product labeling will take 1 hour
per response. FDA estimates that the
submission of final product information
will also take 1 hour per response. The
agency estimates that approximately 200
respondents will submit their device
labeling and product information 3
times annually. The agency estimates
that it will take respondents 2 hours to
convert their word or PDF labeling and
product information into an SPL format
using SPL authoring software. The main
task involved in this conversion is
copying the content from one document
VerDate Mar<15>2010
17:22 May 17, 2010
Jkt 220001
(Word or PDF) to another (SPL). SPL
authors may copy a paragraph from a
Word or PDF document and paste the
text into the appropriate section of an
SPL document. In instances where an
SPL author needs to create a table, the
table text may be copied from Word or
PDF document and pasted into each
table cell in the SPL document.
Conversion software vendors have
designed tools that will import the
Word or PDF version of the final
labeling and product information, and
within minutes, automatically generate
the SPL documents. Once the document
PO 00000
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Fmt 4703
Sfmt 4703
is in the SPL format device
manufacturers can then submit their
product labeling through FDA’s ESG.
The agency estimates the burden
associated with entering the SPL
labeling and product information into
the ESG is 1 hour per response. The
agency based its estimates on the
number of premarket submissions
cleared by FDA for home use from 1976
to the present as well as experience with
the electronic submission process of
registration and listing data elements.
E:\FR\FM\18MYN1.SGM
18MYN1
Federal Register / Vol. 75, No. 95 / Tuesday, May 18, 2010 / Notices
Dated: May 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–11810 Filed 5–17–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on DSKH9S0YB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Imaging and Radiation Therapy.
Date: June 8, 2010.
Time: 1 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Syed M. Quadri, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6210,
MSC 7804, Bethesda, MD 20892, 301–435–
1211, quadris@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Vector Biology Study Section.
Date: June 9–10, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monticello, 1075 Thomas
Jefferson Street, NW., Washington, DC 20007.
Contact Person: Liangbiao Zheng, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
MSC 7808, Bethesda, MD 20892, 301–402–
5671, zhengli@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Auditory System
Study Section.
Date: June 9–10, 2010.
Time: 8:30 a.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Mar<15>2010
17:22 May 17, 2010
Jkt 220001
Place: One Washington Circle Hotel, One
Washington Circle, NW., Washington, DC
20037.
Contact Person: Lynn E. Luethke, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5166,
MSC 7844, Bethesda, MD 20892, (301) 806–
3323, luethkel@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; ARRA:
Somatosensory and Chemosensory Systems
Competitive Revisions.
Date: June 9, 2010.
Time: 2 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle, NW., Washington, DC 20005.
Contact Person: M. Catherine Bennett,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7846, Bethesda, MD 20892, 301–435–
1766, bennettc3@csr.nih.gov.
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Chemo/Dietary Prevention Study
Section.
Date: June 10–11, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street,
NW., Washington, DC 20036.
Contact Person: Sally A Mulhern, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6198,
MSC 7804, Bethesda, MD 20892, (301) 408–
9724, mulherns@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Biodata Management and Analysis
Study Section.
Date: June 10–11, 2010.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Latham Hotel, 3000 M Street, NW.,
Washington, DC 20007.
Contact Person: Mark Caprara, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5156,
MSC 7844, Bethesda, MD 20892, 301–435–
1042, capraramg@mail.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Cell Death in Neurodegeneration
Study Section.
Date: June 10–11, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Washington DC,
1250 22nd Street, NW., Washington, DC
20037.
Contact Person: Kevin Walton, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5200,
MSC 7846, Bethesda, MD 20892, 301–435–
1785, kevin.walton@nih.hhs.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
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Fmt 4703
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27793
Sciences Integrated Review Group;
Pregnancy and Neonatology Study Section.
Date: June 10, 2010.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Michael Knecht, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6176,
MSC 7892, Bethesda, MD 20892, (301) 435–
1046, knechtm@csr.nih.gov.
Name of Committee: Biology of
Development and Aging Integrated Review
Group; Cellular Mechanisms in Aging and
Development Study Section.
Date: June 10–11, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin St. Francis, 335 Powell
Street, San Francisco, CA 94102.
Contact Person: John Burch, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3213,
MSC 7808, Bethesda, MD 20892, 301–408–
9519, burchjb@csr.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Neurological, Aging and Musculoskeletal
Epidemiology Study Section.
Date: June 10–11, 2010.
Time: 8 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Guest Suites, 1707
Fourth Street, Santa Monica, CA 90401.
Contact Person: Heidi B. Friedman, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1012A,
MSC 7770, Bethesda, MD 20892, 301–435–
1721, hfriedman@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Virology—A Study Section.
Date: June 10–11, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin St. Francis, 335 Powell
Street, San Francisco, CA 94102.
Contact Person: Joanna M. Pyper, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3198,
MSC 7808, Bethesda, MD 20892, (301) 435–
1151, pyperj@csr.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group; Neurotechnology
Study Section.
Date: June 10, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Washington DC,
1515 Rhode Island Avenue, NW.,
Washington, DC 20005.
Contact Person: Robert C. Elliott, PhD,
Scientific Review Officer, Center for
E:\FR\FM\18MYN1.SGM
18MYN1
Agencies
[Federal Register Volume 75, Number 95 (Tuesday, May 18, 2010)]
[Notices]
[Pages 27791-27793]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11810]
[[Page 27791]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0229]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Invitation to Manufacturers and Distributors to
Voluntarily Submit Final Product Labeling and Information
Electronically for all Devices Cleared by the Food and Drug
Administration for Home Use; Notice of Pilot Program
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 and
to allow 60 days for public comment in response to the notice. This
notice solicits comments regarding the request that manufacturers and
distributors of all devices cleared by FDA for home use voluntarily
submit final product labeling and information electronically as a part
of a pilot program to be conducted by FDA's Center for Devices and
Radiological Health (CDRH). FDA is requesting that manufacturers and
distributors for these products submit final product labeling and
information in a standard Structured Product Labeling (SPL) format that
we intend to eventually place on a home use device product portal that
will be accessible to the public.
DATES: Submit written or electronic comments on the collection of
information by July 19, 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 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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 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.
Invitation to Manufacturers and Distributors of Devices Cleared by FDA
for Home Use to Voluntarily Submit Final Product Labeling and
Information Electronically (OMB Control Number 0910--New)
For purposes of this pilot program, FDA generally considers a home
use device to be a medical device intended for users in a non-clinical
environment that is managed partly or wholly by the user, where the
device may require adequate labeling for home use and may require
training by a licensed heath care provider in order to be used safely
and effectively.
In June 2001, FDA created the Center for Devices and Radiological
Health (CDRH) Home Health Care Committee (HHCC) to review CDRH's
involvement in addressing problems that arise when devices are used in
the home environment. After meeting with various stakeholders, the HHCC
agreed with the stakeholders' recommendation that promoting the safe
use of medical devices presented a significant health challenge for
which the HHCC could focus CDRH's educational outreach efforts. As a
result, FDA is seeking manufacturers and distributors of devices
cleared for home use to voluntarily participate in a pilot program
involving the submission of final product labeling and additional
product information electronically.
Section 510(j)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360(j)(1)(B)(i)), requires persons who register
and list a restricted device to provide, among other things, a copy of
all labeling to FDA. Section 510(j)(1)(B)(ii) of the act requires
persons who register and list a device that is not restricted to
provide the label and package insert and a representative sampling of
any other labeling to FDA. For this pilot program, we are requesting
manufacturers and distributors of medical devices cleared for home use
to electronically submit final product labeling as well as the
following information, if not included in product labeling:
Device Product Information
Proprietary name
Descriptive name
Model or catalog number
FDA listing number
Manufacturer Information
Manufacturer name
Manufacturer address
Manufacturer 800 number
Manufacturer Web site
Distributor Information
Distributor name
Distributor address
Distributor 800 number
Distributor Web site
Characteristics
Allergens
Single use or reusable
Sterile
Storage temperature
Storage humidity
Size
Storage environment
Picture of device
MRI compatible
Marketing Information
Status
Prescription or OTC
Components and Accessories
Components needed to operate the device
Accessories compatible with the device
Pictures of components and compatible accessories
Directions for Use
Intended use of the device
Indications for use
Route, method, and frequency of administration
[[Page 27792]]
Summary of safety and effectiveness
Assembly or installation instructions
Calibration instructions
Instructions for use for the layperson
Warnings
Precautions
Contraindications
Side effects
Cleaning, disinfecting, and sterilization instructions
Safety information
In Vitro Diagnostic Devices
Test code
Value range
Special information for this test
If this information is not a part of your current final product
labeling or information, FDA is requesting that you submit the
information as a part of this pilot program. The purpose of the pilot
program is twofold. First the pilot program will enable regulated
industry to provide feedback that will assist FDA in developing
guidance for industry on the electronic submission and availability of
final labeling and product information for devices cleared for home
use. Second, the pilot program will enable the public and regulated
industry to view the information and instructions for use for such
devices as a part of CDRH's planned medical device portal for devices
cleared for home use. It is our expectation that the portal,
established as a part of this pilot program, will increase the
likelihood that users--home health nurses, patients, and caregivers--
will have continuous access to home use labeling information and
instructions for use to help ensure the safe and effective use of
devices cleared for home use. In order for manufacturers and
distributors to submit final labeling and product information they will
need to do so in the SPL format. To create an SPL file and submit it to
FDA, a respondent would need the following tools: A computer,
appropriate software, access to the Internet, knowledge of terminology
and standards, and access to FDA's Electronic Submissions Gateway (ESG)
(https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm). The ESG is an agency-wide means for accepting electronic
regulatory submissions. The FDA ESG enables the secure submission of
regulatory submissions. Instructions and information regarding the
creation of an SPL file can be found at https://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Most respondents
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 cost associated with obtaining the software. In 2008, FDA
collaborated with GlobalSubmit (https://globalsubmit.com/home/Home/tabid/37/Default.aspx) to make available free SPL authoring software
that SPL authors may utilize to create new SPL documents or edit
previous versions. After the SPL is created, the respondent would
upload the file through the ESG. The Internet portal can be found at
https://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM162419.pdf.
Prior to uploading an SPL file, one must obtain a digital certificate.
Instructions regarding obtaining a digital certificate used with FDA's
ESG and uploading the SPL file for submission can be found at
www.fda.gov/esg/default.htm. The digital certificate binds together the
owner's name and a pair of electronic keys (a public and a private key)
that can be used to encrypt and sign documents. A fee of up to
approximately $20.00 is charged for the digital certificate. FDA is not
calculating this small fee as cost of this information collection
because manufacturers and distributors will have already secured a
digital certificate as they are required to do so when they register
and list.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Respondents Response Total Hours
----------------------------------------------------------------------------------------------------------------
Collecting Final 200 3 600 2 1,200
Labeling and
Product
Information
----------------------------------------------------------------------------------------------------------------
Conversion of 200 3 600 2 1,200
Word or PDF
Final Labeling
and Product
Information into
SPL
----------------------------------------------------------------------------------------------------------------
Submission of SPL 200 3 600 1 600
into ESG
----------------------------------------------------------------------------------------------------------------
Total 3,000
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that the collection of final product labeling will
take 1 hour per response. FDA estimates that the submission of final
product information will also take 1 hour per response. The agency
estimates that approximately 200 respondents will submit their device
labeling and product information 3 times annually. The agency estimates
that it will take respondents 2 hours to convert their word or PDF
labeling and product information into an SPL format using SPL authoring
software. The main task involved in this conversion is copying the
content from one document (Word or PDF) to another (SPL). SPL authors
may copy a paragraph from a Word or PDF document and paste the text
into the appropriate section of an SPL document. In instances where an
SPL author needs to create a table, the table text may be copied from
Word or PDF document and pasted into each table cell in the SPL
document. Conversion software vendors have designed tools that will
import the Word or PDF version of the final labeling and product
information, and within minutes, automatically generate the SPL
documents. Once the document is in the SPL format device manufacturers
can then submit their product labeling through FDA's ESG. The agency
estimates the burden associated with entering the SPL labeling and
product information into the ESG is 1 hour per response. The agency
based its estimates on the number of premarket submissions cleared by
FDA for home use from 1976 to the present as well as experience with
the electronic submission process of registration and listing data
elements.
[[Page 27793]]
Dated: May 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11810 Filed 5-17-10; 8:45 am]
BILLING CODE 4160-01-S