Federal Register / Vol. 73, No. 90 / Thursday, May 8, 2008 / Notices 26119 

Dated: April 30, 2008. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E8–10215 Filed 5–7–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0063] (formerly 

Docket No. 2008N–0016) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Exports: 

Notification and Recordkeeping 

Requirements 

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 June 9, 

2008. 

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: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–0482. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

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. 

Exports: Notification and 

Recordkeeping Requirements—(OMB 

Control Number 0910–0482)—Extension 

The respondents to this information 

collection are exporters who have 

notified FDA of their intent to export 

unapproved products that may not be 

sold or marketed in the United States as 

allowed under section 801(e) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 381(e)). In general, 

the notification identifies the product 

being exported (e.g. name, description, 

and in some cases, country of 

destination) and specifies where the 

notification should be sent. These 

notifications are sent only for an initial 

export; subsequent exports of the same 

product to the same destination (or, in 

the case of certain countries identified 

in section 802(b) of the act (21 U.S.C. 

382(b)), to any of those countries would 

not result in a notification to FDA. 

The recordkeepers to this information 

collection are exporters who export 

human drugs, biologics, devices, animal 

drugs, foods and cosmetics that may not 

be sold in the United States to maintain 

records demonstrating their compliance 

with the requirements in section 

801(e)(1) of the act. 

The total burden estimate of 39,120 is 

based on the number of notifications 

received by the relevant FDA centers in 

fiscal year 2007, or the last year the 

figures were available. 

In the Federal Register of January 28, 

2008 (73 FR 4874), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. No comments were received. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1.101(d) and (e) 400 3 1,200 15 18,000 

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1.101(b) and (c) 320 3 960 22 21,120 

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

Dated: May 1, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–10204 Filed 5–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Anti-Infective Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Anti-Infective 

Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on July 16, 2008, from 8 a.m. to 5 

p.m. 

Location: Food and Drug 

Administration, Center for Drug 

Evaluation and Research Advisory 

mstockstill on PROD1PC66 with NOTICES