[Federal Register Volume 75, Number 95 (Tuesday, May 18, 2010)]
[Notices]
[Pages 27791-27793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11810]
[[Page 27791]]
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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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information 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 http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44.U.S.C. 3502(3) and 5 CFR
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
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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)
(http://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 http://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 (http://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
http://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\
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No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Respondents Response Total Hours
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Collecting Final 200 3 600 2 1,200
Labeling and
Product
Information
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Conversion of 200 3 600 2 1,200
Word or PDF
Final Labeling
and Product
Information into
SPL
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Submission of SPL 200 3 600 1 600
into ESG
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Total 3,000
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\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