Federal Register / Vol. 75, No. 95 / Tuesday, May 18, 2010 / Notices 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 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, 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 

mstockstill on DSKH9S0YB1PROD with NOTICES

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) (http://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 http://

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 (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 BURDEN1

Activity No. of 

Respondents 

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 3,000 

1There 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 95 / Tuesday, May 18, 2010 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

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. 

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 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES