[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.


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    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