17656 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Notices 

Dated: March 23, 2011. 

Seth F. Chamberlain, 

Reports Clearance Officer. 

[FR Doc. 2011–7340 Filed 3–29–11; 8:45 am] 

BILLING CODE 4184–37–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0492] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Medical Devices: Recommended 

Glossary and Educational Outreach To 

Support Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Medical Devices: Recommended 

Glossary and Educational Outreach to 

Support Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

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: In the 

Federal Register of January 7, 2011 (76 

FR 1169), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0553. The 

approval expires on March 31, 2014. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: March 24, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–7387 Filed 3–29–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0606] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Additional Listing 

Information for Medical Device 

Registration and Listing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 April 29, 

2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0387. Also 

include the FDA 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, e-mail: 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Additional Listing Information for 

Medical Device Registration and 

Listing—(OMB Control Number 0910– 

0387)—Extension 

The Food and Drug Administration 

Amendments Act of 2007 (FDAAA), 

enacted September 27, 2007, requires 

that device establishment registrations 

and listings under 21 U.S.C. 360(p) 

(including the submission of updated 

information) be submitted to the 

Secretary of Health and Human Services 

(the Secretary) by electronic means, 

unless the Secretary grants a request for 

waiver of the requirement, because the 

use of electronic means is not 

reasonable for the person requesting the 

waiver. The collections of information 

under sections 222, 223, and 224 of 

FDAAA have been approved under 

OMB control number 0910–0625. 

Registration by electronic means for 

device establishments replaced FDA 

Forms 2891 and 2891a, ‘‘Registration of 

Device Establishment,’’ and FDA Form 

2892, ‘‘Medical Device Listing,’’ with 

FDA Form 3673, ‘‘Device Registration 

and Listing Module.’’ The scope of this 

information collection addresses only 

the reporting and recordkeeping 

requirements by non-electronic means 

under § 807.31 (21 CFR 807.31). 

Under § 807.31(a) through (d), each 

owner or operator is required to 

maintain an historical file containing 

the labeling and advertisements in use 

on the date of initial listing, and in use 

after October 10, 1978, but not before 

the date of initial listing. The owner or 

operator must maintain in the historical 

file any labeling or advertisements in 

which a material change has been made 

anytime after initial listing, but may 

discard labeling and advertisements 

from the file 3 years after the date of the 

last shipment of a discontinued device 

by an owner or operator. Section 

807.31(e) requires that the owner or 

operator be prepared to submit to FDA 

copies of: (1) All device labeling, (2) all 

device labeling and representative 

advertising, or (3) only representative 

package inserts, depending upon 

whether the device is subject to the 

regulatory controls under sections 514 

and 515 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360d and 360e), or restrictions imposed 

by 21 CFR 801.109 or otherwise by 

section 520(e) of the FD&C Act (21 

U.S.C. 360j(e)). 

The information collected under these 

provisions is used by FDA to identify: 

(1) Firms subject to FDA’s regulations, 

(2) geographic distribution of firms in 

order to effectively allocate FDA’s field 

resources for inspections, and (3) the 

class of the device that determines the 

frequency of inspection. As a result, 

when complications occur with a 

particular device or component, all 

manufacturers of similar or related 

devices can easily be identified. 

The likely respondents to this 

information collection are domestic and 

foreign device establishments who must 

register and submit a device list to FDA, 

e.g., establishments engaged in the 

manufacture, preparation, propagation, 

compounding, assembly, or processing 

of medical devices intended for human 

use and commercial distribution. 

The annual respondent reporting 

burden for device establishment 

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