Federal Register / Vol. 70, No. 177 / Wednesday, September 14, 2005 / Notices 54393 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

860.123 6 1 6 500 3,000 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on current trends and actual 

reclassification petitions received, FDA 

anticipates that six petitions will be 

submitted each year. The time required 

to prepare and submit a reclassification 

petition, including the time needed to 

assemble supporting data, averages 500 

hours per petition. This average is based 

upon estimates by FDA administrative 

and technical staff that are familiar with 

the requirements for submission of a 

reclassification petition, have consulted 

and advised manufacturers on these 

requirements, and have reviewed the 

documentation submitted. 

Dated: September 7, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18221 Filed 9–13–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004D–0251] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Requests for Inspection by an 

Accredited Person Under the 

Inspection by Accredited Persons 

Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Requests for Inspection by an 

Accredited Person Under the Inspection 

by Accredited Persons Program’’ 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 June 7, 2005 (70 FR 

33179), 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 0910–0569. The 

approval expires on August 31, 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. 05–18222 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–0186] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; State Enforcement 

Notifications 

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 October 14, 

2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. 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: Fumie Yokota, Desk Officer 

for FDA, FAX: 202–395–6974. 

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 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

State Enforcement Notifications—21 

CFR 100.2(d) (OMB Control Number 

0910–0275)—Extension 

Section 310(b) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 337(b)) authorizes States to 

enforce certain sections of the act in 

their own names, but provides that 

States must notify FDA before doing so. 

Section 100.2(d) (21 CFR 100.2(d)) sets 

forth the information that a State must 

provide to FDA in a letter of notification 

when it intends to take enforcement 

action under the act against a particular 

food located in the State. The 

information required under § 100.2(d) 

will enable FDA to identify the food 

against which the State intends to take 

action and advise the State whether 

Federal action has been taken against it. 

With certain narrow exceptions, Federal 

enforcement action precludes State 

action under the act. 

In the Federal Register of June 20, 

2005 (70 FR 35446), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. FDA received no comments. 

FDA estimates the burden of this 

collection of information as follows: