54392 Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0554] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Irradiation in the Production, 

Processing, and Handling of Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Irradiation in the Production, 

Processing, and Handling of Food’’ has 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of March 29, 2005 (70 

FR 15863), 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 0910–0549. The 

approval expires on June 30, 2008. A 

copy of the supporting statement for this 

information collection is available on 

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

ohrms/dockets. 

Dated: September 7, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18165 Filed 9–13–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0350] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Reclassification 

Petitions for Medical Devices 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

reclassification petitions for medical 

devices. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 14, 2005. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

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, 

including each proposed extension of an 

existing 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. 

Reclassification Petitions for Medical 

Devices—21 CFR 860.123 (OMB Control 

Number 0910–0138)—Extension 

FDA has the responsibility under 

sections 513(e), 513(f), 514(b), 515(b), 

and 520(l) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360c(e), 360c(f), 360d(b), 360e(b), and 

360j(l)) and part 860 (21 CFR part 860), 

subpart C, to collect data and 

information contained in 

reclassification petitions. The 

reclassification provisions of the act 

allow any person to petition for 

reclassification of a device from any one 

of the three classes (I, II, and III) to 

another class. The reclassification 

content regulation (§ 860.123) requires 

the submission of sufficient, valid 

scientific evidence demonstrating that 

the proposed classification will provide 

a reasonable assurance of safety and 

effectiveness of the device for its 

intended use. The reclassification 

provisions of the act serve primarily as 

a vehicle for manufacturers to seek 

reclassification from a higher to a lower 

class, thereby reducing the regulatory 

requirements applicable to a particular 

device. The reclassification petitions 

requesting classification from class III to 

class II or class I, if approved, provide 

an alternative route to the market in lieu 

of premarket approval for class III 

devices. 

Respondents are device 

manufacturers seeking reclassification. 

FDA estimates the burden of this 

collection of information as follows: