81616 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project. Fax: 202– 

395–7285. E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: December 22, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–32592 Filed 12–27–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0198] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Premarket Notification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Premarket Notification’’ 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, e-mail: 

Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 11, 2010 (75 

FR 48696), 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 0910–0120. The 

approval expires on December 31, 2013. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: December 21, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32508 Filed 12–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0447] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Devices; 

Third Party Review Program Under the 

Food and Drug Administration 

Modernization Act 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by January 27, 

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 0910–0375. 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. 

Medical Devices; Third Party Review 

Program Under the Food and Drug 

Administration Modernization Act— 

(OMB Control Number 0910–0375)— 

Extension 

Section 210 of the Food and Drug 

Administration Modernization Act 

(FDAMA) established section 523 of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360m), 

directing FDA to accredit persons in the 

private sector to review certain 

premarket notifications (510(k)s). 

Participation in this third-party review 

program by accredited persons is 

entirely voluntary. A third party 

wishing to participate will submit a 

request for accreditation to FDA. 

Accredited third-party reviewers have 

the ability to review a manufacturer’s 

510(k) of the FD&C Act (21 U.S.C. 360) 

submission for selected devices. After 

reviewing a submission, the reviewer 

will forward a copy of the 510(k) 

submission, along with the reviewer’s 

documented review and 

recommendation to FDA. Third-party 

reviewers should maintain records of 

their 510(k) reviews and a copy of the 

510(k) for a reasonable period of time, 

usually a period of 3 years. 

This information collection will allow 

FDA to continue to implement the 

accredited person review program 

established by FDAMA and improve the 

efficiency of 510(k) review for low- to 

moderate-risk devices. 

Respondents to this information 

collection are businesses or other forprofit organizations. 

I. Reporting 

510(k) Reviews Conducted by 

Accredited Third Parties 

According to FDA’s data in 2009, the 

Agency has experienced that the 

number of 510(k)s submitted for thirdparty review is approximately 260 

annually, which is 26 annual reviews 

per each of the 10 accredited reviewers. 

II. Recordkeeping 

Third party reviewers are required to 

keep records of their review of each 

submission. According to FDA’s in 

2009, the Agency anticipates 

approximately 260 submissions of 

510(k)s for third-party review per year. 

In the Federal Register of September 

22, 2010 (75 FR 57801), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment; however, it was not PRA 

related. 

FDA estimates the burden of this 

collection of information as follows: 


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