69576 Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices 

petitions for § 10.85 (advisory opinions), 

the agency received approximately 2 

requests annually, each required an 

average of 16 hours of preparation time. 

Dated: November 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22668 Filed 11–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0290] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Importer’s Entry 

Notice 

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 December 

16, 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 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. 

Importer’s Entry Notice—(OMB Control 

Number 0910–0046)—Extension 

Section 801 of the Federal Food, Drug, 

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

381) charges FDA with the following 

responsibilities: (1) Ensuring that 

foreign-origin FDA-regulated foods, 

drugs, cosmetics, medical devices, and 

radiological health products offered for 

import into the United States meet the 

same requirements of the act as do 

domestic products; and (2) preventing 

shipments from entering the country if 

they are not in compliance. 

The information collected by FDA 

consists of the following: (1) Product 

code, an alpha-numeric series of 

characters that identifies each product 

FDA regulates; (2) FDA country of 

origin, the country where the FDAregistered or FDA-responsible firm is 

located; (3) FDA manufacturer, the party 

who manufactured, grew, assembled, or 

otherwise processed the goods (if more 

than one, the last party who 

substantially transformed the product); 

(4) shipper, the party responsible for 

packing, consolidating, or arranging the 

shipment of goods to their final 

destinations; (5) quantity and value of 

the shipment; and (6) if appropriate, 

affirmation of compliance, a code that 

conveys specific FDA information, such 

as registration number, foreign 

government certification, etc. This 

information is collected electronically 

by the entry filer via the U.S. Customs 

Service’s Automated Commercial 

System at the same time that person 

files an entry for import with the U.S. 

Custom Service. FDA uses this 

information to make admissibility 

decisions about FDA-regulated products 

offered for import into the United 

States. 

The annual reporting burden is 

derived from the basic processes and 

procedures used in fiscal year (FY) 

1995. The total number of entries 

submitted to the automated system in 

FY 2004 was 6,626,827. The total 

number of entries less the disclaimer 

entries will represent the total FDA 

products entered into the automated 

system. A total of 53 percent of all 

entries entered into the automated 

system were entries dealing with FDAregulated products. The number of 

respondents is a count of filers who 

submit entry data for foreign-origin 

FDA-regulated products. The estimated 

reporting burden is based on 

information obtained by FDA while 

contacting potential respondents. 

Disclaimer entries are not FDA 

commodities. 

In the Federal Register of August 3, 

2005 (70 FR 44656), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. One comment was received. 

The Government of Canada is 

concerned that the methodology used 

does not take into consideration the 

additional burden of FDA’s interim final 

prior notice and regulation rules which 

came into effect December 2003. They 

urged FDA to amend the methodology 

used to take into consideration the 

additional burden associated with all 

requirements for providing information 

concerning foreign-origin FDA-regulated 

foods. Of particular concern is the 

burden resulting from the 

implementation of the prior notice and 

regulation rules under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002. 

The burden for the prior notice and 

regulation rules is reported and 

approved under OMB Control Number 

0910–0520; expiration date October 31, 

2006. 

FDA estimates the burden of the 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 U.S.C. Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

801 3,406 1,089 3,709,134 .14 519,279 

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

Federal Register / Vol. 70, No. 220 / Wednesday, November 16, 2005 / Notices 69577 

Dated: November 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22671 Filed 11–15–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0427] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

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 

requirements for filing objections and 

requests for a hearing on a regulation or 

order. 

DATES: Submit written or electronic 

comments on the collection of 

information by January 17, 2006. 

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: 

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

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. 

Filing Objections and Requests for a 

Hearing on a Regulation or Order—21 

CFR Part 12 (OMB Control Number 

0910–0184)—Extension 

Under part 12 (21 CFR part 12), 

§ 12.22, issued under section 701(e)(2) 

of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 371(e)(2)), sets 

forth the instructions for filing 

objections and requests for a hearing on 

a regulation or order under § 12.20(d). 

Objections and requests must be 

submitted within the time specified in 

§ 12.20(e). Each objection for which a 

hearing has been requested must be 

separately numbered and specify the 

provision of the regulation or the 

proposed order. In addition, each 

objection must include a detailed 

description and analysis of the factual 

information and any other document, 

with some exceptions, supporting the 

objection. Failure to include this 

information constitutes a waiver of the 

right to a hearing on that objection. FDA 

uses the description and analysis to 

determine whether a hearing request is 

justified. The description and analysis 

may be used only for the purpose of 

determining whether a hearing has been 

justified under § 12.24 and do not limit 

the evidence that may be presented if a 

hearing is granted. 

Respondents to this information 

collection are those parties that may be 

adversely affected by an order or 

regulation. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

12.22 10 1 10 20 200 

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